METAMUCIL THERAPY FOR REGULARITY- psyllium husk powder

Metamucil by

Drug Labeling and Warnings

Metamucil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each TEASPOON)

Psyllium husk approximately 3.4 g

Purpose

Fiber therapy for regularity

Uses

• for relief of occasional constipation (irregularity)

Warnings

Choking

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.

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

Stop use and ask a doctor if

• constipation lasts more than 7 days
• rectal bleeding occurs

These may be signs of a serious condition.

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. & 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.

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

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DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

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.

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)