ANTACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone liquid 
FREDS, INC

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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FREDS ANTACID max

Active ingredients (in each 5 mL teaspoonful)

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

Purposes

Antacid

Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • upset stomach due to these symptoms
  • symptoms of 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

Keep out of reach of children.

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

Directions

  • shake well before use
  • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
  • do not take more than 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor

Other information

each 5 mL teaspoonful 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

package Label

FREDS

ANTACID MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-619
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-619-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/201202/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/201202/01/2021
Labeler - FREDS, INC (005866116)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(55315-619) , pack(55315-619)

Revised: 11/2020
 
FREDS, INC