Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder
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- NDC Code(s): 37000-023-04, 37000-023-10
- 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.
Drug Label Information
Updated March 29, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TABLESPOON)
- Purpose
- Uses
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Choking
Taking this product without adequate fluid may cause it to swell and block
your throat or esophagus andmay 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.Allergy alert
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
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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. 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
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
MetaMUCIL
DAILY FIBER SUPPLEMENT THERAPY FOR REGULARITY
100% NATURAL PSYLLIUM HUSK
4 in 1 MultiHealth
- Helps you feel less hungry between meals*
- Helps maintain healthy blood sugar levels as part of your diet*
- Helps lower cholesterol to promote heart health †
- Promotes digestive health*
made with REAL SUGAR
ORANGE SMOOTH SINGLES
30 PACKETS
30 0.43 OZ (12 g) POWDER PACKETS/NETWT 12.9 OZ (366 g)
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INGREDIENTS AND APPEARANCE
METAMUCIL THERAPY FOR REGULARITY
psyllium husk powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-023 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 12 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCROSE (UNII: C151H8M554) 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:37000-023-04 30 in 1 CARTON 03/31/1989 1 NDC:37000-023-10 12 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:37000-023-10 12 g in 1 POUCH; Type 0: Not a Combination Product 03/31/1989 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/31/1989 Labeler - The Procter & Gamble Manufacturing Company (004238200)