Hyoscyamine Sulfate label

Hyoscyamine Sulfate

Hyoscyamine Sulfate Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as a premedication and following general anesthesia, hydrOXYzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.  Atropine and other belladonna alkaloids are not affected by the drug.  HydrOXYzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydrOXYzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies.  The physician should reassess periodically the usefulness of the drug for the individual patient.

History

There is currently no drug history available for this drug.

Other Information

HydrOXYzine hydrochloride has the chemical name of 2-[2-[4- (p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride.

Structure

HydrOXYzine hydrochloride occurs as a white, odorless powder which is very soluble in water.

Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydrOXYzine HCl. Inactive ingredients include: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, polyethylene glycol, polysorbate 80, and titanium dioxide.

Hyoscyamine Sulfate Manufacturers

  • Proficient Rx Lp
    Hyoscyamine Sulfate | Blenheim Pharmacal, Inc.
    No Recall

    Hyoscyamine Sulfate | Blenheim Pharmacal, Inc.

    Hyoscyamine Sulfate | Blenheim Pharmacal, Inc.

    For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested:  Adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses.

    For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus:  adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses.

    As a sedative when used as a premedication and following general anesthesia: 50-100 mg for adults and 0.6 mg/kg of body weight in children.

    When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

    As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.

  • Hyoscyamine Sulfate | Kaiser Foundation Hospitals
    No Recall

    Hyoscyamine Sulfate | Kaiser Foundation Hospitals

    Hyoscyamine Sulfate | Kaiser Foundation Hospitals

    Dosage may be adjusted according to the conditions and severity of symptoms. Place Hyoscyamine Sulfate SL Tablets 0.125 mg under the tongue, allowing the tablet to rapidly disintegrate. May be taken with or without water. Tablets may also be placed on the tongue for oral disintegration, chewed, or swallowed orally.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Franklin Pharmaceutical Llc
    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc
    No Recall

    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc

    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc

    Dosage may be adjusted according to the conditions and severity of symptoms.

  • County Line Pharmaceuticals, Llc
    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc
    No Recall

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • County Line Pharmaceuticals, Llc
    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc
    No Recall

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Dosage may be adjusted according to the conditions and severity of symptoms. Place a Hyoscyamine Sulfate Orally Disintegrating Tablet on tongue, allowing the tablet to rapidly disintegrate and be swallowed. May be taken with or without water.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Franklin Pharmaceutical Llc
    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc
    No Recall

    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc

    Hyoscyamine Sulfate | Franklin Pharmaceutical Llc

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults And Pediatric Patients 12 Years Of Age And Older

    1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric Patients 2 To Under 12 Years Of Age

    ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • County Line Pharmaceuticals, Llc
    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc
    No Recall

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Hyoscyamine Sulfate | County Line Pharmaceuticals, Llc

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Paddock Laboratories, Inc.
    Hyoscyamine Sulfate | Paddock Laboratories, Inc.
    No Recall

    Hyoscyamine Sulfate | Paddock Laboratories, Inc.

    Hyoscyamine Sulfate | Paddock Laboratories, Inc.
    Adults and pediatric patients 12 years or older:

    1 or 2 tablets every 12 hours. Dosage may be adjusted to 1 tablet every 8 hours if needed. Do not exceed 4 tablets in 24 hours. Tablets should be swallowed whole.

    Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

    Pediatric patients 6 to under 12 years of age:

    1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. Tablets should be swallowed whole.

    Note: This product is not recommended for use in children under six years of age.

  • Hyoscyamine Sulfate | Rebel Distributors Corp
    No Recall

    Hyoscyamine Sulfate | Rebel Distributors Corp

    Hyoscyamine Sulfate | Rebel Distributors Corp

    Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Hyoscyamine Sulfate | Rebel Distributors Corp
    No Recall

    Hyoscyamine Sulfate | Rebel Distributors Corp

    Hyoscyamine Sulfate | Rebel Distributors Corp

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Virtus Pharmaceuticals
    Hyoscyamine Sulfate | Virtus Pharmaceuticals
    No Recall

    Hyoscyamine Sulfate | Virtus Pharmaceuticals

    Hyoscyamine Sulfate | Virtus Pharmaceuticals

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Hyoscyamine Sulfate Tablets, USP must be taken orally.

    Adults and pediatric patients 12 years of age and older

    1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age

    ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Virtus Pharmaceuticals
    Hyoscyamine Sulfate | Virtus Pharmaceuticals
    No Recall

    Hyoscyamine Sulfate | Virtus Pharmaceuticals

    Hyoscyamine Sulfate | Virtus Pharmaceuticals

    Dosage may be adjusted according to the conditions and severity of symptoms. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg must be placed on the tongue when it will dissolve in seconds, then swallow with saliva. Administering with liquid is not necessary.

    Adults and pediatric patients 12 years of age and older

    1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age

    ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Paddock Laboratories, Llc
    Hyoscyamine Sulfate | Paddock Laboratories, Llc
    No Recall

    Hyoscyamine Sulfate | Paddock Laboratories, Llc

    Hyoscyamine Sulfate | Paddock Laboratories, Llc
    Adults and pediatric patients 12 years of age or older:

    1 to 2 oral tablets three to four times a day, thirty minutes to one hour before meals and at bedtime, the dosage being adjusted as needed and tolerated. Do not exceed 12 tablets in 24 hours.

    Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

    Pediatric patients 6 to under 12 years of age:

    1/2 to 1 oral tablet three to four times a day, thirty minutes to one hour before meals and at bedtime. Dosage should be individualized by physician according to patient's needs and tolerance. Do not exceed 6 tablets in 24 hours.

    Note: This product is not recommended for use in children under six years of age.

  • Paddock Laboratories, Llc
    Hyoscyamine Sulfate | Rxchange Co.
    No Recall

    Hyoscyamine Sulfate | Rxchange Co.

    Hyoscyamine Sulfate | Rxchange Co.

    Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
    After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
    Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.
    Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease
    Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
    The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
    In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.
    The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).
    The availability of four tablet strengths facilitates dosage adjustment.
    In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient’s dose should be reviewed and adjusted as required.
    Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
    In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.
    Dysmenorrhea
    For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

  • Paddock Laboratories, Llc
    Hyoscyamine Sulfate | Publix Super Markets Inc
    No Recall

    Hyoscyamine Sulfate | Publix Super Markets Inc

    Hyoscyamine Sulfate | Publix Super Markets Inc
    • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor

    Shake well before use. Before using the first time, unlock pump, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock pump to maintain child resistance.

  • Clinical Solutions Wholesale
    Hyoscyamine Sulfate | Clinical Solutions Wholesale
    No Recall

    Hyoscyamine Sulfate | Clinical Solutions Wholesale

    Hyoscyamine Sulfate | Clinical Solutions Wholesale

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Aidarex Pharmaceuticals Llc
    Hyoscyamine Sulfate | Aidarex Pharmaceuticals Llc
    No Recall

    Hyoscyamine Sulfate | Aidarex Pharmaceuticals Llc

    Hyoscyamine Sulfate | Aidarex Pharmaceuticals Llc

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Pd-rx Pharmaceuticals, Inc.
    Hyoscyamine Sulfate | Pd-rx Pharmaceuticals, Inc.
    No Recall

    Hyoscyamine Sulfate | Pd-rx Pharmaceuticals, Inc.

    Hyoscyamine Sulfate | Pd-rx Pharmaceuticals, Inc.

    Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Bryant Ranch Prepack
    Hyoscyamine Sulfate | Bryant Ranch Prepack
    No Recall

    Hyoscyamine Sulfate | Bryant Ranch Prepack

    Hyoscyamine Sulfate | Bryant Ranch Prepack

    Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.

  • Proficient Rx Lp
    Hyoscyamine Sulfate | Ascent Consumer Products, Inc.
    No Recall

    Hyoscyamine Sulfate | Ascent Consumer Products, Inc.

    Hyoscyamine Sulfate | Ascent Consumer Products, Inc.

    Directions

    Adults and children 4 years and over:      use 1/2 - 1 packet per 4 fl oz (120 mL)up to every two hours as needed

    Children under 4 years: Consult a physician

    See enclosed instruction sheet for complete directions and proper use

  • Hyoscyamine Sulfate | Carilion Materials Management
    No Recall

    Hyoscyamine Sulfate | Carilion Materials Management

    Hyoscyamine Sulfate | Carilion Materials Management

    Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.

    1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Adults and pediatric patients 12 years of age and older:

    1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours. Pediatric patients 2 to under 12 years of age:

  • Kmr Pharmaceuticals Llc
    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc
    No Recall

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Dosage may be adjusted according to the condition and severity of symptoms. May be taken with or without water.

    Adults and adolescents 12 years of age and older: 1 to 2 tablets orally three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage may be increased to every four hours as needed. Do not exceed 12 tablets in 24 hours.

  • Kmr Pharmaceuticals Llc
    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc
    No Recall

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Dosage may be adjusted according to the condition and severity of symptoms. May be taken with or without water.

    Adults and adolescents 12 years of age and older: 1 to 2 tablets sublingually three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage may be increased to every four hours as needed. Do not exceed 12 tablets in 24 hours.

  • Kmr Pharmaceuticals Llc
    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc
    No Recall

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Dosage may be adjusted according to the condition and severity of symptoms. Tablets can be chewed or placed on tongue for disintegration. May be taken with or without water.

    Adults and adolescents 12 years of age and older: 1 to 2 tablets three or four times a day, thirty minutes to one hour before meals and at bedtime. Dosage may be increased to every four hours as needed. Do not exceed 12 tablets in 24 hours.

  • Kmr Pharmaceuticals Llc
    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc
    No Recall

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Hyoscyamine Sulfate | Kmr Pharmaceuticals Llc

    Adults and children 12 years or older: 1 or 2 tablets every 12 hours. Dosage may be adjusted to 1 tablet every 8 hours if needed. Do not exceed 4 tablets in 24 hours. Tablets should be swallowed whole.

    Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.

  • Preferred Pharmaceuticals Inc.
    Hyoscyamine Sulfate | Preferred Pharmaceuticals Inc.
    No Recall

    Hyoscyamine Sulfate | Preferred Pharmaceuticals Inc.

    Hyoscyamine Sulfate | Preferred Pharmaceuticals Inc.

    Dosage may be adjusted according to the conditions and severity of symptoms.

    Adults and pediatric patients 12 years of age and older: 1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.

    Pediatric patients 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.