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Regular Strength antacid anti gas

Dosage form: suspension
Ingredients: ALUMINUM HYDROXIDE 400mg in 10mL, MAGNESIUM HYDROXIDE 400mg in 10mL, SIMETHICONE 40mg in 10mL
Labeler: Publix Super Markets Inc
NDC Code: 56062-357

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.

Publix Super Markets, Inc. Regular Strength Antacid/Anti-Gas Drug Facts

Active ingredients (in each 10 mL)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purposes

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

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

When using this product

do not exceed 120 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.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions
shake well before use
measure with dosing cup provided
adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
do not take more than 120 mL in any 24 hour period
do not use the maximum dosage for more than 2 weeks
children under 12 years: ask a doctor
mL = milliliter

Other information
each 10 mL contains: magnesium 175 mg
does not meet USP requirements for preservative effectiveness
store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, simethicone emulsion, sorbitol, sorbitol solution

Principal Display Panel

ANTACID/ANTI-GAS

regular strength

ORIGINAL FLAVOR

Soothing relief of

heartburn

acid indigestion

sour stomach

ALCOHOL 0.2%

12 FL OZ (355 mL)

REGULAR STRENGTH  ANTACID ANTI GAS
aluminum hydroxide, magnesium hydroxide, simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE400 mg  in 10 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE400 mg  in 10 mL
SIMETHICONE (SIMETHICONE) SIMETHICONE40 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
BUTYLPARABEN 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PEPPERMINT OIL 
PROPYLPARABEN 
WATER 
SORBITOL 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINT (lemon, original) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-357-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/12/1994
Labeler - Publix Super Markets Inc (006922009)

Revised: 06/2017
 
Publix Super Markets Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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