STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

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

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Care One (American Sales Company)
INN (International Name):
BISMUTH SUBSALICYLATE
Composition:
BISMUTH SUBSALICYLATE 525 mg in 30 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Upset stomach reliever/Antidiarrheal relieves - travelers' diarrhea - diarrhea - upset stomach due to overindulgence in food and drink, including: heartburn gas indigestion nausea fullness belching - heartburn - gas - indigestion - nausea - fullness - belching
Authorization status:
OTC monograph final
Authorization number:
41520-425-08, 41520-425-12

STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

Care One (American Sales Company)

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.

----------

Drug Facts

Active ingredient (in each 30 mL)

Bismuth subsalicylate 525 mg

Purpos e

Upset stomach reliever/Antidiarrheal

Us es

relieves

travelers' diarrhea

diarrhea

upset stomach due to overindulgence in food and drink, including:

heartburn

indigestion

nausea

fullness

belching

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms ahould 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

diabetes

gout

arthritis

anticoagulation (thinning the blood)

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 childen.

In case of overdose, get medical help or contact a Posion Control Center right away. (1-800-222-1222)

Directions

mL = milliliter

shake well before using

measure only with dosing cup provided. Do not use any other dosing device.

keep dosing cup with product

adults and children 12 years and over:

30 mL (1 dose) every 1/2 to 1 hour as needed

do not exceed 8 doses (240 mL) in 24 hours

use until diarrhea stops but not more than 2 days

children under 12 years of age: ask a doctor

drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

each 30 mL contains: sodium 14 mg

each 30 mL contains: salicylate 248 mg

sugar free

keep tightly closed

protect from freezing

avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose,

purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®†

REGULAR STRENGTH

STOMACH RELIEF

Bismuth subsalicylate 525 mg

Upset Stomach Reliever/Antidiarrheal

Cherry Flavor

RELIEVES

NAUSEA, HEARTBURN, INDIGESTION, UPSET STOMACH, DIARRHEA

FL OZ (mL)

†This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol®

is a registered trademark of The Procter & Gamble Company.

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP

OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Package Label

CAREONE Reg ular Streng th Stomach Relief

STOMACH RELIEF REGULAR STRENGTH

bismuth subsalicylate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41520 -425

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (BISMUTH CATION - UNII:ZS9 CD1I8 YE,

SALICYLIC ACID - UNII:O414PZ4LPZ)

BISMUTH

SUBSALICYLATE

525 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

D&C RED NO . 2 2 (UNII: 16 78 RKX8 RT)

D&C RED NO . 2 8 (UNII: 76 7IP0 Y5NH)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SALICYLIC ACID (UNII: O414PZ4LPZ)

SO DIUM SALICYLATE (UNII: WIQ1H8 5SYP)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

METHYLCELLULO SE ( 150 0 CPS) (UNII: P0 NTE48 36 4)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:41520 -425-

237 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/31/20 15

2

NDC:41520 -425-

355 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/31/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt335

0 1/31/20 15

Labeler -

Care One (American Sales Company) (809183973)

Care One (American Sales Company)

Revised: 10/2019

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