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NDC 69842-0528-05 Maximum strength Stomach Relief 525 mg/30mL Details

Maximum strength Stomach Relief 525 mg/30mL

Maximum strength Stomach Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. 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: 69842-0528-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate

Product Information

NDC	69842-0528
Product ID	69842-528_6e37d3f7-9589-427c-ae57-03b39833caf9
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	Maximum strength Stomach Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bismuth Subsalicylate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	525
Active Ingredient Units	mg/30mL
Substance Name	BISMUTH SUBSALICYLATE
Labeler Name	CVS
Pharmaceutical Class	Bismuth [CS], Bismuth [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part335
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0528-05 (69842052805)

Pricing Information	N/A
NDC Package Code	69842-528-05
Billing NDC	69842052805
Package	355 mL in 1 BOTTLE (69842-528-05)
Marketing Start Date	2008-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 75326a55-7cf3-411e-96a3-a6aef6c35ca5 Details

Active ingredient (in each 30 mL)

Bismuth subsalicylate 1050 mg

Purpose

Upset stomach reliever and anti-diarrheal

SPL UNCLASSIFIED SECTION

Uses

relieves:

diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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

bloody or black stool
an ulcer
a bleeding problem

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 of 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
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 immediately.

Directions

shake well before use
adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every hour as needed
do not exceed 4 doses (8 tbsp or 120 mL) 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 30 mL or 2 Tbsp contains: sodium 8 mg, salicylate 471 mg, potassium 25 mg
protect from freezing
avoid excessive heat (over 104oF or 40oC)
dosage cup provided

Inactive ingredients

benzoic acid, D&C red 22, D&Cred 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

*Compare to the active ingredient in PEPTO-BISMOL® Maximum Strength

Maximum Strength Stomach Relief

Bismuth Subsalicylate 1050mg

Upset Stomach Reliever & Anti-diarrheal

Soothing Relief for 5 symptoms:

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH STOMACH RELIEF

bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-528
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-528-05	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2008
2	NDC:69842-528-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	09/08/2008

Labeler - CVS (062312574)

Revised: 8/2017

Document Id: 6e37d3f7-9589-427c-ae57-03b39833caf9

Set id: 75326a55-7cf3-411e-96a3-a6aef6c35ca5

Version: 1

Effective Time: 20170808