Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder
- NDC Code(s): 37000-024-04, 37000-024-10
- 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 June 14, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TEASPOON)
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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water.
Adults 12 yrs. & older
1 packet in 8 oz of liquid at the first sign of irregularity.
Can be taken up to 3 times daily.
6 – 11 yrs. 1/2 packet in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor
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
- Inactive ingredients
SPL UNCLASSIFIED SECTION
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
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
This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.
Ask a doctor before use if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits persisting for 2 weeks
Ask a doctor or pharmacist before use if you
are taking any other drug. Take
this product 2 or more hours before or after other drugs. Laxatives may affect how
other drugs work.
Stop use and ask a doctor if
• constipation lasts more than 7 days
• rectal bleeding occurs
• you fail to have a bowel movement
These may be signs of a serious condition.
PRINCIPAL DISPLAY PANEL
PSYLLIUM FIBER SUPPLEMENT THERAPY FOR IRREGULARITY
Heart Health by Lowering Cholesterol†
Healthy Blood Sugar Levels*
Digestive Health *
not a low calorie food
†See back for information about soluble fiber and heart disease
ORANGE fiber powder / naturally and artificially flavored
30-0.21 OZ (5.8g) POWDER PACKETS/NET WT 6.20z (176g)
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:37000-024-04 30 in 1 CARTON 12/15/1994 1 NDC:37000-024-10 0.021 g in 1 POUCH; Type 0: Not a Combination Product 2 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)