STOMACH RELIEF ULTRA 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)
Available from:
P & L Development, LLC
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 indigestion nausea gas fullness belching - heartburn - indigestion - nausea - gas - fullness - belching
Authorization status:
OTC monograph final
Authorization number:
49580-0842-8

STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate liquid

P & L Development, 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.

----------

Drug Facts

Active ingredient (in each 15 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 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

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 (1-800-222-1222) right away.

Directions

do not take more than 8 doses (120 mL) in 24 hours

use until diarrhea stops but not more than 2 days

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

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:

15 mL (1 dose) every 1/2 hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's

diarrhea

15 mL (1 dose) every 1/2 as needed for overindulgence (upset stomach, heartburn, indigestion,

nausea)

children under 12 years of age: ask a doctor

Other information

each 15 mL contains: sodium 6 mg

each 15 mL contains: salicylate 227 mg

low sodium

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

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol® Ultra*

Ultra Stomach Relief

Bismuth subsalicylate 525 mg

upset stomach reliever/antidiarrheal

Relieves:

heartburn

indigestion

nausea

upset stomach

diarrhea

2x strength per ounce†

alcohol free

sugar free

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.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

READYinCASE Stomach Relief Ultra

STOMACH RELIEF ULTRA STRENGTH

bismuth subsalicylate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 58 0 -0 8 42

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)

BISMUTH

SUBSALICYLATE

525 mg

in 15 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)

P & L Development, LLC

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:49 58 0 -0 8 42-

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

Pro duc t

0 2/28 /20 19

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 2/28 /20 19

Labeler -

P & L Development, LLC (101896231)

Revised: 3/2019

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