SAMS WEST- psyllium husk capsule

SAMS WEST by

Drug Labeling and Warnings

SAMS WEST by is a Otc medication manufactured, distributed, or labeled by SAM'S WEST INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

Psyllium husk approximately 0.52 g

Purpose

Fiber Laxative

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, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

• ▪ Take this product 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.
• ▪ Adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
• ▪ children 12 years and under: Ask a doctor
• ▪ Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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

• ▪ each capsule contains: potassium 5 mg
• ▪ capsules are sealed using a band around the middle
• ▪ store at room temperature tightly closed to protect from humidity
• ▪ contains a 100% natural, therapeutic fiber
• ▪ tamper evident: do not use if printed inner seal under cap is broken or missing

Inactive ingredients

caramel color, edible ink, gelatin, polysorbate 80

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 400 Capsules

NDC 68196-119-40

Member’s Mark®

QUALITY GUARANTEED

Compare to the Metamucil® MultiHealth Capsules® active ingredient*

100% natural psyllium fiber

Fiber capsules

Fiber supplement laxative for regularity

• Helps maintain blood sugar levels as part of your diet**
• Helps lower cholesterol to promote heart health††
• Promotes digestive health**

GLUTEN FREE

400 CAPSULES

LABORATORY TESTED

QUALITY ASSURED

††See back for information about soluble fiber and heart disease

**THESE STAEMENTS HAVE NOT BEEN EVALUATED BY FOOD AND DRUG ADMINSTRATION, THIS PRODUCT IS NOT INTEDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

GLUTEN FREE (If you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product. This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.)

DISTRIBUTED BY: SAM’S WEST, INC.

BENTONVILLE, AR 72716

For comments or suggestions, call us toll-free at 1-866-467-2748 from 8:00 a.m. to 5:00 p.m. CST Mon-Fri

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® Capsules.

INGREDIENTS AND APPEARANCE

SAMS WEST 
psyllium husk capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	0.52 g

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	RP119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-119-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/21/2019

Labeler - SAM'S WEST INC (051957769)