FDA Label for Metamucil Therapy For Regularity

View Indications, Usage & Precautions

Metamucil Therapy For Regularity Product Label

The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202


Active Ingredient (In Each Teaspoon)



Psyllium husk approximately 3.4 g


Purpose



Fiber therapy for regularity


Uses



  • for relief of occasional constipation (irregularity)

Choking



Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.


Otc - Do Not Use



Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.


Allergy Alert



This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.


Otc - Ask Doctor



Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting

Otc - Stop Use



Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs
  • These may be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, contact a doctor or a Poison Control Center right away.


Directions



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. & older1 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.


Other Information



  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • do not use if printed inner seal is broken or missing
  • store at room temperature tightly closed to protect from humidity
  • see bottom of canister for expiration date

Inactive Ingredients



aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor


Questions?



1-800-983-4237


Principal Display Panel - 425 G Canister Label



NDC 37000-024-02

Doctor
#1
Recommended Brand

100% NATURAL PSYLLIUM HUSK
daily fiber supplement
therapy for regularity

Meta-
mucil ®

MultiHealth Fiber

    Helps lower cholesterol
    to promote heart health* Promotes digestive health Helps maintain healthy
    blood sugar
    levels*†

    SUGAR-FREE
    not a low calorie food

    orange smooth
    fiber powder / naturally and artificially flavored

    NET WT 15 OZ (425 g)

    72 DOSES

    *See back for information about soluble fiber and heart disease
    and maintaining healthy blood sugar levels.


* Please review the disclaimer below.