PEPTO-BISMOL- bismuth subsalicylate tablet

Pepto-Bismol by

Drug Labeling and Warnings

Pepto-Bismol by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Package Label

INGREDIENTS AND APPEARANCE

PEPTO-BISMOL 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73097-010(NDC:58933-477)
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: 73097-010-40	20 in 1 CARTON	07/15/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-010-02	2 in 1 POUCH; Type 0: Not a Combination Product	07/15/2019
3	NDC: 73097-010-50	25 in 1 CARTON	07/15/2019
3		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	07/15/2019

Labeler - Savings Distributors LLC (010527359)

Establishment
Name	Address	ID/FEI	Business Operations
Savings Distributors LLC		010527359	repack(73097-010)