Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder
37000-024-06, view more37000-024-07, 37000-024-08, 37000-024-10, 37000-024-44
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 11, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TEASPOON)
Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking.
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.
This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.
Ask a doctor before use if you have
- a sudden change in bowel habits persisting for 2 weeks
- abdominal pain, nausea or vomiting
Stop use and ask a doctor if
- constipation lasts more than 7 days
- rectal bleeding occurs
These may be signs of a serious condition.
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.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 425 g Canister Label
100% NATURAL PSYLLIUM HUSK
daily fiber supplement
therapy for regularity
to promote heart health*
- Promotes digestive health †
- Helps maintain
blood sugar levels*†
not a low calorie food
fiber powder / naturally and artificially flavored
NET WT 15 OZ (425 g)
*See back for information about soluble fiber and heart disease
and maintaining healthy blood sugar levels.
- Helps lower cholesterol
INGREDIENTS AND APPEARANCE
METAMUCIL THERAPY FOR REGULARITY
psyllium husk powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 5.8 g Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) Product Characteristics Color brown Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-024-07 1040 g in 1 CANISTER; Type 0: Not a Combination Product 12/15/1994 2 NDC:37000-024-06 660 g in 1 CANISTER; Type 0: Not a Combination Product 12/15/1994 3 NDC:37000-024-02 425 g in 1 CANISTER; Type 0: Not a Combination Product 12/15/1994 4 NDC:37000-024-01 283 g in 1 CANISTER; Type 0: Not a Combination Product 12/15/1994 5 NDC:37000-024-08 174 g in 1 CANISTER; Type 0: Not a Combination Product 12/15/1994 6 NDC:37000-024-04 30 in 1 CARTON 12/15/1994 12/01/2021 6 NDC:37000-024-10 0.021 g in 1 POUCH; Type 0: Not a Combination Product 7 NDC:37000-024-44 44 in 1 CARTON 12/15/1994 7 NDC:37000-024-10 0.021 g in 1 POUCH; Type 0: Not a Combination Product 8 NDC:37000-024-10 0.021 g in 1 POUCH; Type 0: Not a Combination Product 12/15/1994 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/15/1994 Labeler - The Procter & Gamble Manufacturing Company (004238200)