CALCIUM CARBONATE- calcium carbonate suspension 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Calcium Carbonate

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)

Purpose

Antacid

Uses

Relieves:

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product,do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Keep out of reach of children.

Directions

  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other information

  • store at 20° - 25°C (68° - 77°F)
  • do not freeze
  • Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:
NDC 0121-0766-16:16 fl oz (473 mL) bottle
NDC 0121-4766-05:5 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Calcium Carbonate

GENERIC: Calcium Carbonate

DOSAGE: SUSPENSION

ADMINSTRATION: ORAL

NDC: 70518-2265-0

NDC: 70518-2265-1

COLOR: pink

FLAVOR: BUBBLE GUM

PACKAGING: 5 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

  • CALCIUM CARBONATE 1250mg in 5mL

INACTIVE INGREDIENT(S):

  • D&C RED NO. 33
  • SACCHARIN CALCIUM
  • WATER
  • PROPYLPARABEN
  • METHYLPARABEN
  • PROPYLENE GLYCOL
  • SORBITOL
  • GLYCERIN
  • XANTHAN GUM
  • ANHYDROUS CITRIC ACID
  • FD&C RED NO. 40

Remedy_Label

MM2

CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2265(NDC:0121-0766)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-2265-010 in 1 BOX08/16/201910/16/2023
1NDC:70518-2265-15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/16/201910/16/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 8/2023
Document Id: 03876453-bb1d-5fc0-e063-6294a90adcfd
Set id: 645c1e53-aa8b-4a57-9184-77e5a2b9bd6c
Version: 4
Effective Time: 20230822
 
REMEDYREPACK INC.