CALCIUM CARBONATE 10 GR (648 MG) (ANTACID)- calcium carbonate 10gr (648 mg) tablet 
Aphena Pharma Solutions - Tennessee, LLC

----------

Drug Facts

Active ingredient (in each tablet)

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

relieves

Warnings


Ask a doctor before use if you have

  • kidney stones
  • a calcium-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

Other information

Inactive ingredients

acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or comments?

1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Repackaging Information

Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count648 mg
18071610-301-80

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20190711JH

PRINCIPAL DISPLAY PANEL - 648 mg

NDC 71610-301 - Calcium Carbonate 648 mg Tablets
Bottle Label 648 mg

CALCIUM CARBONATE 10 GR (648 MG)  (ANTACID)
calcium carbonate 10gr (648 mg) tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-301(NDC:0536-1206)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code PH046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-301-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2019
2NDC:71610-301-65100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2019
3NDC:71610-301-80180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
4NDC:71610-301-92270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00102/28/2019
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585repack(71610-301)

Revised: 1/2025
Document Id: 2b49322a-dc2e-f4a1-e063-6294a90a6cff
Set id: ac839363-94fd-4c60-b5b6-70e4488ce1dd
Version: 2
Effective Time: 20250109
 
Aphena Pharma Solutions - Tennessee, LLC