Search by Drug Name or NDC

NDC 69842-0479-08 Stomach Relief 525 mg/1 Details

Stomach Relief 525 mg/1

Stomach Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY. The primary component is BISMUTH SUBSALICYLATE.

MedlinePlus Drug Summary

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Related Packages: 69842-0479-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	69842-0479
Product ID	69842-479_0d22a055-c4f7-4316-85a3-e9c8e77f1dbc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stomach Relief
Proprietary Name Suffix	Ultra
Non-Proprietary Name	Bismuth Subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	525
Active Ingredient Units	mg/1
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	CVS PHARMACY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	n/a

Package

Package Images

NDC 69842-0479-08 (69842047908)

Pricing Information	N/A
NDC Package Code	69842-479-08
Billing NDC	69842047908
Package	1 BOTTLE, PLASTIC in 1 CARTON (69842-479-08) / 24 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-03-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 73801441-13a4-4e06-ab6f-aa5fa2d13b28 Details

Active ingredient ( in each caplet)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/antidiarrheal

Uses

relieves

travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
- indigestion
- fullness
- gas
- nausea
- belching
- heartburn

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 chances 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)
gout
diabetes
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
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

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
swallow with water; do not chew
adults and children 12 years and over: 1 caplet every 1/2 to 1 hour as needed. Do not exceed 8 caplets in 24 hours.
do not use for more than 2 days unless directed by a doctor
use until diarrhea stops, but not more than 2 days
children under 12 years: ask a doctor

Other information

each caplet contains: calcium 45 mg, salicylate 206 mg, sodium 3 mg
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat
see end flap for expiration date and lot number

Inactive ingredients

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose,

povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

♥︎CVS

Health®

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

ULTRA

Stomach

Relief

BISMUTH SUBSALICYLATE

525 mg

Upset stomach reliever/

Antidiarrheal

Soothing relief for 5 symptoms:

Heartburn
Indigestion
Upset stomach
Nausea
Diarrhea

Actual Size

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Pepto-Bismol® Ultra.

50844 ORG121974908

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-14236

CVS Quality

Money Back Guarantee

CVS Health 44-749

INGREDIENTS AND APPEARANCE

STOMACH RELIEF ULTRA

bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-479
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	44;749
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-479-08	1 in 1 CARTON	03/02/2021	06/21/2023
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	03/02/2021	06/21/2023

Labeler - CVS PHARMACY (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(69842-479)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(69842-479)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(69842-479)

Revised: 11/2021

Document Id: 0d22a055-c4f7-4316-85a3-e9c8e77f1dbc

Set id: 73801441-13a4-4e06-ab6f-aa5fa2d13b28

Version: 4

Effective Time: 20211109