ANTACID - aluminum hydroxide, magnesium hydroxide, simethicone liquid 
H E B

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.

----------

HEB Antacid

ACTIVE INGREDIENT (in each 10 mL )

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg

PURPOSE

Antacid
Antacid
Antigas

USE(S)

relieves:


WARNINGS

Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE 

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL


NDC 37808-554-05

HEB
Antacid

Aluminum hydroxide, 400 mg
Magnesium hydroxide, 400 mg
Simethicone, 40 mg

Antacid & Antigas

Relief of:



Original Flavored Liquid

12 FL OZ (355 mL)
Alcohol content 0.2% v/v



109



ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-554
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-554-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/13/2021
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(37808-554)

Revised: 12/2021
Document Id: f294cf44-fb21-4b2e-8b7c-efd41416c6b2
Set id: f294cf44-fb21-4b2e-8b7c-efd41416c6b2
Version: 1
Effective Time: 20211213
 
H E B