SUNMARK ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone liquid 
McKesson

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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McKesson Antacid Drug Facts

Active ingredient (in each 5 mL teaspoon)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
upset stomach due to these symptoms
•
pressure and bloating commonly referred to as gas

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.

When using this product

do not exceed 12 teaspoonsful (60 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Keep out of reach of children.

Directions

•
shake well before use
•
adults and children 12 years and older: take 2-4 teaspoonsful (10-20 mL) between meals, at bedtime, or as directed by a doctor
•
children under 12: ask a doctor

Other information

•
each teaspoon contains: calcium 50 mg, magnesium 175 mg, potassium 10 mg and sodium 2 mg
•
does not meet USP requirements for preservative effectiveness
•
store at 20°-25°C

Inactive ingredients

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, potassium citrate, propylparaben, purified water, simethicone emulsion, sorbitol

Principal Display Panel

Compare to Mylanta® Maximum Strength Active Ingredients

Antacid

Maximum Strength

Antacid/Anti-Gas

Fast Acting

Fast soothing relief of heartburn, acid indigestion, sour stomach & gas

Original

Antacid Front Label

Antacid Front Label

Antacid Back Label

Antacid Front Label

Antacid Back Label

SUNMARK ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-035
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-035-39355 mL in 1 BOTTLE; Type 0: Not a Combination Product10/20/200308/27/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/20/200308/27/2013
Labeler - McKesson (177667227)

Revised: 11/2017
Document Id: ed56eb6f-27d2-431f-a872-bfc6cea5b202
Set id: c6b8312b-f08c-4dc6-9828-776ffc50e29d
Version: 2
Effective Time: 20171118
 
McKesson