PEPTO-BISMOL- bismuth subsalicylate tablet, chewable

Pepto-Bismol by

Drug Labeling and Warnings

Pepto-Bismol by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

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 right away.

Directions

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg, magnesium 9 mg
• salicylate 101 mg
• very low sodium
• avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Questions?

1-800-717-3786

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PRODUCT REPACKAGED AND DISTRIBUTED
WITH PERMISSION OF MANUFACTURER BY:
Lil' Drug Store Products, Inc.,1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 6 Tablet Cello Pack Carton

Coupon Inside! Save 50¢
on your next purchase of one Pepto-Bismol™ product (excludes trial/travel size).

Pepto-
Bismol™

BISMUTH SUBSALICYLATE
UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5
SYMPTOM
Digestive Relief

• heartburn
• indigestion
• nausea
• upset stomach
• diarrhea

6
Chewable
Tablets

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

PEPTO-BISMOL  
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9723
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)
D&C Red No. 27 Aluminum Lake (UNII: ZK64F7XSTX)
Magnesium Stearate (UNII: 70097M6I30)
Mannitol (UNII: 3OWL53L36A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Saccharin Sodium (UNII: SB8ZUX40TY)
Talc (UNII: 7SEV7J4R1U)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	WINTERGREEN	Imprint Code	Pepto;Bismol
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9723-2	2 in 1 CARTON	11/14/2017
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9723-3	3 in 1 CARTON	11/14/2017
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	09/16/2010

Labeler - Lil' Drug Store Products, Inc. (093103646)