Goddess Garden Organics Everyday Natural Sunscreen label

Goddess Garden Organics Everyday Natural Sunscreen

Goddess Garden Organics Everyday Natural Sunscreen Recall

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Side Effects & Adverse Reactions

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache

These could be signs of a serious condition.

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache

These could be signs of a serious condition.

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

  •  temporarily relieves these symptoms due to the common cold:
    • nasal congestion
    • headache
    • minor aches and pains
    • cough
    • sore throat
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily reduces fever

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Goddess Garden Organics Everyday Natural Sunscreen Manufacturers

  • Crossing Cultures, Llc Dba Goddess Garden
    Goddess Garden Organics Everyday Natural Sunscreen | Walgreen Co.
    No Recall

    Goddess Garden Organics Everyday Natural Sunscreen | Walgreen Co.

    Goddess Garden Organics Everyday Natural Sunscreen | Walgreen Co.
    do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
  • Crossing Cultures, Llc Dba Goddess Garden
    Goddess Garden Organics Everyday Natural Sunscreen | Remedyrepack Inc.
    No Recall

    Goddess Garden Organics Everyday Natural Sunscreen | Remedyrepack Inc.

    Goddess Garden Organics Everyday Natural Sunscreen | Remedyrepack Inc.

    Note:  37.5 mg/25 mg = 37.5 mg triamterene and 25 mg hydrochlorothiazide          

    75 mg/50 mg = 75 mg triamterene and 50 mg hydrochlorothiazide

    The usual dose of Triamterene and Hydrochlorothiazide 37.5 mg/25 mg is one or two tablets daily, given as a single dose, with appropriate monitoring of serum potassium (see WARNINGS). The usual dose of Triamterene and Hydrochlorothiazide 75 mg/50 mg is one tablet daily, with appropriate monitoring of serum potassium (see WARNINGS). There is no experience with the use of more than one 75 mg/50 mg tablet daily or more than two 37.5 mg/25 mg tablets daily. Clinical experience with the administration of two 37.5 mg/25 mg tablets daily in divided doses (rather than as a single dose) suggests an increased risk of electrolyte imbalance and renal dysfunction.

    Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be transferred to 75 mg/50 mg product directly. Patients receiving 25 mg hydrochlorothiazide who become hypokalemic may be transferred to a 37.5 mg triamterene/25 mg hydrochlorothiazide directly.

    In patients requiring hydrochlorothiazide therapy and in whom hypokalemia cannot be risked, therapy may be initiated with 37.5 mg/25 mg of triamterene and hydrochlorothiazide. If an optimal blood pressure response is not obtained with 37.5 mg/25 mg of triamterene and hydrochlorothiazide, the dose should be increased to two 37.5 mg/25 mg tablets daily as a single dose, or one 75 mg/50 mg tablet daily. If blood pressure still is not controlled, another antihypertensive agent may be added (see PRECAUTIONS, Drug Interactions).

    Clinical studies have shown that patients taking less bioavailable formulations of triamterene and hydrochlorothiazide in daily doses of 25 mg to 50 mg hydrochlorothiazide and 50 mg to 100 mg triamterene may be safely changed to one 37.5 mg/25 mg of triamterene and hydrochlorothiazide daily. All patients changed from less bioavailable formulations to triamterene and hydrochlorothiazide should be monitored clinically and for serum potassium after the transfer.

     

  • Crossing Cultures, Llc Dba Goddess Garden
    Goddess Garden Organics Everyday Natural Sunscreen | Auromedics Pharma Llc
    No Recall

    Goddess Garden Organics Everyday Natural Sunscreen | Auromedics Pharma Llc

    Goddess Garden Organics Everyday Natural Sunscreen | Auromedics Pharma Llc

    Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of lidocaine hydrochloride injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated.



    There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine hydrochloride injection, USP is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

    These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of  factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease.

    The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of lidocaine hydrochloride injection, USP will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of lidocaine hydrochloride injection, USP may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine hydrochloride is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.

    Epidural Anesthesia

    For epidural anesthesia the following dosage form of lidocaine hydrochloride injection, USP is recommended:

    1% without epinephrine                                  30 mL single dose vials

    Although this solution is intended specifically for epidural anesthesia, it may also be used for infiltration and peripheral nerve block, provided it is employed as a single dose unit.

    This solution contains no bacteriostatic agent.

    In epidural anesthesia, the dosage varies withthe number of dermatomes to be anesthetized (generally 2 to 3 mL of the indicated concentration per dermatome).

    Caudal and Lumbar Epidural Block

    As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of lidocaine hydrochloride injection, USP through the catheter should be avoided, and, when feasible, fractional doses should be administered.

    In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.

  • Crossing Cultures, Llc Dba Goddess Garden
    Goddess Garden Organics Everyday Natural Sunscreen | Apotex Corp.
    No Recall

    Goddess Garden Organics Everyday Natural Sunscreen | Apotex Corp.

    Goddess Garden Organics Everyday Natural Sunscreen | Apotex Corp.

    The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).