PEPTO BISMOL CHEWABLES- bismuth subsalicylate tablet, chewable

Pepto Bismol by

Drug Labeling and Warnings

Pepto Bismol by is a Otc medication manufactured, distributed, or labeled by Procter & Gamble Manufactura S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

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

Keep out of reach of children.

OVERDOSAGE

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 (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
•  2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

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
• 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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

SPL UNCLASSIFIED SECTION

MADE IN MEXICO

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 12 Chewable Tablet Carton

Pepto
Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/ Antidiarrheal

CHEWABLES

5 SYMPTOM

RELIEF

NAUSEA
HEARTBURN
INDIGESTION
UPSET STOMACH
DIARRHEA

12 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

PEPTO BISMOL  CHEWABLES
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58933-011
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
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: 58933-011-02	2 in 1 PACKET; Type 0: Not a Combination Product	06/30/2004
2	NDC: 58933-011-12	2 in 1 CARTON	06/30/2004
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 58933-011-30	5 in 1 CARTON	06/30/2004
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 58933-011-48	8 in 1 CARTON	06/30/2004
4		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 58933-011-04	4 in 1 PACKET; Type 0: Not a Combination Product	06/30/2004
6	NDC: 58933-011-90	3 in 1 BLISTER PACK	10/04/2022
6		5 in 1 CARTON
6		6 in 1 BLISTER PACK; 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	06/30/2004

Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)