Label: METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder
37000-023-07, view more37000-023-10
- 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.
Updated January 8, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TABLESPOON)
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 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.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 1.36 kg Canister
100% Natural Psyllium
Daily fiber supplement/
Therapy for regularity
Helps lower cholesterol
to promote heart health*
- Promotes digestive health †
- Low glycemic index* †
(less than 20 ppm gluten)*
Psyllium fiber powder
Naturally and artificially flavored
NET WT 48.2 OZ (3 LBS) 1.36 kg
*See back for information about soluble fiber and heart disease and for
information about low glycemic index and gluten.
- Helps lower cholesterol
INGREDIENTS AND APPEARANCE
METAMUCIL THERAPY FOR REGULARITY
psyllium husk powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-023 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:37000-023-07 1360 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/1989 2 NDC:37000-023-06 822 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/1989 3 NDC:37000-023-05 575 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/1989 4 NDC:37000-023-04 30 in 1 CARTON 03/31/1989 4 NDC:37000-023-10 12 g in 1 POUCH; Type 0: Not a Combination Product 5 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)