SUPREME ANTACID- calcium carbonate, magnesium hydroxide suspension 
Chain Drug Consortium, LLC

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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PV 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

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 each use
  • adults and children 12 years and older: take 2 to 4

teaspoonfuls, as needed, between meals, at bedtime, or as
directed by a doctor. Do not take more than 18 teaspoonfuls
in 24 hours unless directed by a doctor

  • 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
  • protect from freezing
  • keep tightly closed
  • TAMPER-EVIDENT: Do not use if
    breakaway band on bottle cap is missing or broken.

Inactive ingredients

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

package Label

SUP

SUPREME ANTACID 
calcium carbonate, magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-624
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE135 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-624-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/201209/01/2020
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP LABORATORIES965480861manufacture(68016-624) , pack(68016-624)

Revised: 12/2021
 
Chain Drug Consortium, LLC