METAMUCIL THERAPY FOR REGULARITY- psyllium husk
Procter & Gamble Manufacturing Company

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.

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Metamucil®
Therapy for Regularity

Drug Facts

Active ingredient (in each TABLESPOON)

Psyllium husk approximately 3.4 g

Purpose

Fiber therapy for regularity

Uses

effective in treating occasional constipation and restoring regularity

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 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.

New Users

Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Other information

each tablespoon contains: potassium 30 mg; sodium 5 mg
store at room temperature tightly closed to protect from humidity
see bottom of canister for expiration date
contains a 100% natural, therapeutic fiber

Inactive ingredients

citric acid, FD&C Yellow No. 6, natural and artificial orange flavor, sucrose

Questions?

1-800-983-4237

Dist. by Procter & Gamble, Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 2.73 kg Canister Label

Naturally Sweetened with
Real Sugar

Metamucil®
MultiHealth Fiber

✔: Helps lower cholesterol
to promote heart health*
✔: Promotes digestive health†
✔: Low glycemic index*†
✔: Gluten free
(less than 20 ppm gluten)*

100% Natural Psyllium
Daily fiber supplement/
Therapy for regularity

228

DOSES

2 x 114 Doses

P&G

WORLDWIDE
PARTNER

Orange smooth

Psyllium fiber powder/Naturally and artificially flavored

NET WT 96.4 OZ (6 LBS) 2.73 kg

2 - 114 DOSES (228 DOSES TOTAL)

*See back for information about soluble fiber and heart disease and for information about low glycemic index and gluten.

Principal Display Panel - 2.73 kg Canister Label

METAMUCIL THERAPY FOR REGULARITY
psyllium husk kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-817

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-817-01	1 in 1 PACKAGE

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 CANISTER	1360 g
Part 2	1 CANISTER	1360 g

Part 1 of 2

METAMUCIL THERAPY FOR REGULARITY
psyllium husk powder

Product Information
Item Code (Source)	NDC:37000-023
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	3.4 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-023-07	1360 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	03/31/1989

Part 2 of 2

METAMUCIL THERAPY FOR REGULARITY
psyllium husk powder

Product Information
Item Code (Source)	NDC:37000-023
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	3.4 g in 12 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-023-07	1360 g in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	03/31/1989

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	03/31/1989	08/11/2016

Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2014

Document Id: 3f6c2b25-e7b3-4ae9-983d-aaa66c70361a

Set id: c9e6d2d6-0617-4c76-a826-1e492ffe88f4

Version: 3

Effective Time: 20140923

Procter & Gamble Manufacturing Company

Metamucil® Therapy for Regularity