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MAXIMUM STRENGTH ANTACID by Chain Drug Consortium, LLC

Dosage form: liquid
Ingredients: ALUMINUM HYDROXIDE 400mg in 5mL, MAGNESIUM HYDROXIDE 400mg in 5mL, DIMETHICONE 40mg in 5mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-619

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.

pv ANTACID max

Active ingredients (in each teaspoonful = 5 mL)

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

Purposes

Antacid

Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms 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.

Stop use and ask a doctor if

symptoms last more than 2 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions
  • shake well before use
  • adults and children 12 years and older: take 2 to 4 teaspoonfuls

(10-20 mL), as needed, between meals, at bedtime, or as
directed by a doctor. Do not take more than 12 teaspoonfuls
(60 mL) in 24 hours unless directed by a doctor.

  • children under 12: ask a doctor

Other information
  • each teaspoonful (5 mL) contains: magnesium 165 mg, sodium 1 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed
  • TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions or comments?

1-800-540-3765

package Label

MAXIMUM STRENGTH ANTACID 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-619
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE400 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM (SACCHARIN)  
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:68016-619-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(68016-619), pack(68016-619)

Revised: 12/2017
 
Chain Drug Consortium, LLC

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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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