ANTACID DOUBLE STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid 
Rij Pharmaceutical Corporation

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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Drug Facts

Active ingredients (in each 5 mL) (One teaspoonful)

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

relieves

heartburn
acid indigestion
sour stomach
associated symptoms of gas and upset stomach
overindulgence of food and drink

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

symptoms last for more than 2 weeks

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

shake well before each use
adults and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
do not take more than 12 teaspoonsful in 24 hour period
do not use the maximum dosage for more than 2 weeks
children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
Store at room temperature 15º - 30ºC (59º - 86ºF)
keep tightly closed
protect from freezing
each teaspoon (5 mL) contains: magnesium 165 mg
each teaspoon (5 mL) contains: sodium 1 mg
does not meet USP requirements for preservative effectiveness

Inactive ingredients

flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, xanthan gum and water

Principal Display Panel

Antacid Front Label ImageAntacid Back Label Image

ANTACID DOUBLE STRENGTH 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
SACCHARIN (UNII: FST467XS7D)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
SORBITOL (UNII: 506T60A25R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LEMON OIL (UNII: I9GRO824LL)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-158-05148 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
2NDC:53807-158-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-158)

Revised: 4/2018
Document Id: e38c3353-1842-4e8a-88ed-ef54f7e74c53
Set id: ee1374c6-b7e7-42e4-84ee-452661b0d979
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation