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ANTACID SUPREME

Dosage form: suspension
Ingredients: CALCIUM CARBONATE 400mg in 5mL, MAGNESIUM HYDROXIDE 135mg in 5mL
Labeler: FREDS, INC
NDC Code: 55315-624

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 supreme cherry

Active ingredients (in each 5 mL teaspoonful)

Calcium carbonate 400 mg
Magnesium hydroxide 135 mg

Purpose

Antacid

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
  • overindulgence in food and drink

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 this and all drugs out of the 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 18 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: calcium 160mg, magnesium 55 mg
  • refrigerate after opening to preserve freshness and purity
  • do not freeze
  • keep tightly closed

Inactive ingredients

benzyl alcohol, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sorbic acid, sorbitol solution, xanthan gum

package Label

ANTACID SUPREME 
calcium carbonate, magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-624
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE135 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
WATER 
SACCHARIN SODIUM (SACCHARIN)  
DIMETHICONE 
SORBIC ACID 
SORBITOL 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-624-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/2012
Labeler - FREDS, INC (005866116)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP LABORATORIES965480861manufacture(55315-624), pack(55315-624)

Revised: 12/2017
 
FREDS, 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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