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ANTACID REGULAR STRENGTH by FREDS, INC

Medically reviewed on December 19, 2017

Dosage form: suspension
Ingredients: ALUMINUM HYDROXIDE 200mg in 5mL, MAGNESIUM HYDROXIDE 200mg in 5mL, DIMETHICONE 20mg in 5mL
Labeler: FREDS, INC
NDC Code: 55315-629

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.

FREDS ANTACID original

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

Purposes

Antacid
Antigas

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • 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.

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 24 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 85 mg, sodium 1 mg
  • do not freeze
  • store at room temperature tightly closed

Inactive ingredients

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

package Label

ANTACID REGULAR STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-629
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE200 mg  in 5 mL
DIMETHICONE (DIMETHICONE) DIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM (SACCHARIN)  
SORBITOL 
HYPROMELLOSES 
MICROCRYSTALLINE CELLULOSE 
Packaging
#Item CodePackage Description
1NDC:55315-629-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/01/2015
Labeler - FREDS, INC (005866116)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(55315-629), pack(55315-629)

 
FREDS, INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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