ANTACID- calcium carbonate tablet 
Advance Pharmaceutical Inc.

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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Calcium Carbonate 10 gr (648 mg)

Active Ingredient

(in each tablet)

Calcium Carbonate 10 gr (648 mg)

Purpose

Antacid

Uses

relieves

Warnings

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Questions or Comments

Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

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

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

17ad8654-figure-01

17ad8654-figure-02

Calcium Carbonate 10 gr

Antacid tablets

NDC: 17714-025-01 – 100 COUNT

NDC: 17714-025-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

ANTACID 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-025
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE648 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (off) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code AP;025
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-025-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/06/1990
2NDC:17714-025-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/06/1990
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/06/1990
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-025)

Revised: 12/2017
Document Id: 60f41580-e08d-faad-e053-2a91aa0a9076
Set id: 0108b97f-02e9-4f86-9f33-cde4f919affd
Version: 2
Effective Time: 20171222
 
Advance Pharmaceutical Inc.