DIGESTIVE RELIEF- bismuth subsalicylate tablet, film coated

Digestive Relief by

Drug Labeling and Warnings

Digestive Relief by is a Otc medication manufactured, distributed, or labeled by SAFEWAY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

PURPOSE

Purpose

Upset stomach reliever and anti-diarrheal

Uses

relieves:

• ▪ travelers’ diarrhea
• ▪ diarrhea

upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness

WARNINGS

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are

• ▪ allergic to salicylates (including aspirin)
• ▪ taking other salicylate products.

Do not use if you have

• ▪ an ulcer
• ▪ a bleeding problem
• ▪ bloody or black stool

Ask a doctor before use if you have

• ▪ fever
• ▪ mucus in the stool

Ask a doctor or pharmacist before use if you are

taking any drug for

• ▪ anticoagulation (thinning the blood)
• ▪ diabetes
• ▪ gout
• ▪ arthritis

When using this product

a temporary but harmless darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if

• ▪ symptoms get worse or last more than 2 days
• ▪ ringing in the ears or loss of hearing occurs
• ▪ diarrhea lasts more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Directions

• ▪ swallow with water, do not chew
• ▪ adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
• ▪ do not exceed 8 doses (16 caplets) in 24 hours
• ▪ use until diarrhea stops but not more than 2 days
• ▪ children under 12 years: ask a doctor
• ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other Information

• ▪ each caplet contains: calcium 27 mg, sodium 3 mg
• ▪ salicylate 99 mg
• ▪ low sodium
• ▪ sugar free
• ▪ store at room temperature

Questions or comments?

1-866-467-2748

Inactive Ingredients

calcium carbonate, crospovidone, D&C Red No. 27, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

PRINCIPAL DISPLAY PANEL

NDC# 21130-125-40

Compare to the active ingredient Pepto-Bismol®*

Digestive Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/ Antidiarrheal

5 Symptoms Digestive Relief

• Heartburn
• Indigestion
• Nausea
• Upset Stomach
• Diarrhea

40 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.

INGREDIENTS AND APPEARANCE

DIGESTIVE RELIEF 
bismuth subsalicylate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL (Caplet)	Size	16mm
Flavor		Imprint Code	RP125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-125-40	1 in 1 CARTON	10/05/2020
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	10/05/2020

Labeler - SAFEWAY (009137209)