Metamucil Therapy For Regularity label

Metamucil Therapy For Regularity

Metamucil Therapy For Regularity Recall

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Side Effects & Adverse Reactions

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

Legal Issues

There is currently no legal information available for this drug.

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

Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Limitations of Use
In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.

History

There is currently no drug history available for this drug.

Other Information

Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone.

Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc.

USP dissolution test pending.

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Metamucil Therapy For Regularity Recall

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Metamucil Therapy For Regularity Manufacturers

Cardinal Health
No Recall
Metamucil Therapy For Regularity | Ingenus Pharmaceuticals, Llc
2.1 Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA)
The recommended dosage of modafinil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
2.2 Dosage in Shift Work Disorder (SWD)
The recommended dosage of modafinil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
2.3 Dosage Modifications in Patients with Severe Hepatic Impairment
In patients with severe hepatic impairment, the dosage of modafinil tablets should be reduced to one-half of that recommended for patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
2.4 Use in Geriatric Patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12–72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 - 72 hours. 6 - 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 - 72 hours. 6 - 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
The Procter & Gamble Manufacturing Company
No Recall
Metamucil Therapy For Regularity | The Procter & Gamble Manufacturing Company
Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.
Adults 12 yrs. & older 1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12 – 72 hours. 6 – 11 yrs. ½ adult dose in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
New Users
Start with 1 dose per day; gradually increase to 3 doses per day as necessary.