PEPTO-BISMOL- bismuth subsalicylate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Savings Distributors LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Upset stomach reliever and antidiarrheal relieves ● travelers' diarrhea ● diarrhea ● upset stomach due to overindulgence in food and drink, including: ● heartburn ● indigestion ● nausea ● gas ● belching ● fullness
Authorization status:
OTC monograph final
Authorization number:
73097-010-02, 73097-010-40, 73097-010-50

PEPTO-BISMOL- bismuth subsalicylate tablet

Savings Distributors LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pepto-Bis mol

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

PEPTO-BISMOL

bismuth subsalicylate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 9 7-0 10 (NDC:58 9 33-477)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)

BISMUTH SUBSALICYLATE 26 2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Savings Distributors LLC

MANNITO L (UNII: 3OWL53L36 A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

D&C RED NO . 2 7 ALUMINUM LAKE (UNII: ZK6 4F7XSTX)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

pink

S core

no sco re

S hap e

ROUND

S iz e

16 mm

Flavor

WINTERGREEN

Imprint Code

Pe pto ;Bismo l

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 9 7-0 10 -40

20 in 1 CARTON

0 7/15/20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:730 9 7-0 10 -0 2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 7/15/20 19

3

NDC:730 9 7-0 10 -50

25 in 1 CARTON

0 7/15/20 19

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt335

0 7/15/20 19

Labeler -

Savings Distributors LLC (010527359)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Savings Distributo rs LLC

0 10 527359

re pa c k(730 9 7-0 10 )

Revised: 7/2019

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