CALCIUM CARBONATE 10 GR (648 MG) (ANTACID)- calcium carbonate 10gr (648 mg) tablet 
Aphena Pharma Solutions - Tennessee, 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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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 Supplied section 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 finalpart33102/28/2019
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-301)

Revised: 7/2019
Document Id: 1115445c-a777-44ea-8a2c-660293e4d544
Set id: ac839363-94fd-4c60-b5b6-70e4488ce1dd
Version: 1
Effective Time: 20190711
 
Aphena Pharma Solutions - Tennessee, LLC