PEPTO RELIEF- bismuth subsalicylate tablet, chewable

Pepto Relief by

Drug Labeling and Warnings

Pepto Relief by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals, Inc, Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

.

Active Ingredient

(in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/Upset stomach reliever

Uses

• Controls diarrhea
• Relieves upset stomach due to overindulgence in food or drink

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: Do not take if you are

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

  Do not use

• If you have bloody or black stool
• If you have an ulcer or bleeding problem

  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
• 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 right away.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• repeat dosage every 1/2 to 1 hour as needed
• do not take more than 8 doses in 24 hours
• use until diarrhea stops but not more than 2 days
• adults and children 12 years and over: 2 tablets
• children under 12 years: ask a doctor

Other Information

• Each tablet contains: calcium 77 mg, salicylate 102 mg
• store at 15°-30°C (59°-86°F)
• protect from moisture

INACTIVE INGREDIENT

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

INGREDIENTS AND APPEARANCE

PEPTO RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
CHERRY (UNII: BUC5I9595W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-102-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015
2	NDC: 54738-102-48	48 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	06/01/2015

Labeler - Richmond Pharmaceuticals, Inc (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-102)