EQUALINE MAXIMUM STRENGTH STOMACH RELIEF - bismuth subsalicylate liquid 
Supervalu Inc.

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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Equaline Maximum Strength Stomach Relief Liquid

ACTIVE INGREDIENT(in each 30 mL)

Bismuth subsalicylate 1050 mg

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:


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




DO NOT USE IF YOU HAVE

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

taking any drug for 


WHEN USING THIS PRODUCT

a temporary, but harmless darkening of the stool and/or tongue may occur

STOP USE AND ASK DOCTOR IF

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

OTHER INFORMATION

INACTIVE INGREDIENTS

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum

PRINCIPAL DISPLAY PANEL

NDC 41163-937-05
compate to Pepto-Bismol Maximum Strength active ingredient*
EQUALINE
maximum strength
stomach relief liquid
bismuth subsalicylate 1050 mg per 30 mL
(upset stomach reliever/antidiarrheal)

5 symptom digestive relief:



12 FL OZ (354 mL)


47


EQUALINE MAXIMUM STRENGTH STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-937
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-937-05354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/23/2018
2NDC:41163-937-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/23/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33509/23/2018
Labeler - Supervalu Inc. (006961411)

Revised: 1/2022
Document Id: 20f6499c-d78f-46d9-a3f4-32db00a403be
Set id: 716a7b86-4f6e-493d-ba29-d81f6ecafbf2
Version: 4
Effective Time: 20220111
 
Supervalu Inc.