ANTACID FRUIT FLAVOR- antacid tablet 
Cintas

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

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

Temporarily relieves

heartburn
sour stomach
upset stomach associated with these symptoms

Warnings

Do not use

more than 15 tablets in a 24 hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Ask Doctor or Pharmacist before use if you are

If Pregnancy or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

[Enter Keep Out of Reach of Children here]

Directions

adults and children 12 years of age and older: chew 2-4 tablets as symptoms occur; repeat hourly if symptoms return or directed by a doctor

children under 12 years of age: ask a doctor

Inactive Ingredients

D&C Yellow #6, flavors, magnesium stearate and sorbitol

Package/Label Principal Display Panel

W:\SPL-OTC\Cintas\Antacid Frout\115089_XP_Antacid_box_100ct_v2.jpg
ANTACID  FRUIT FLAVOR
antacid tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize16mm
FlavorORANGEImprint Code RH024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42961-124-64250 in 1 BOX; Type 0: Not a Combination Product06/19/201410/01/2018
2NDC:42961-124-08100 in 1 BOX; Type 0: Not a Combination Product06/19/201410/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/19/201410/01/2018
Labeler - Cintas (056481716)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705analysis(42961-124) , label(42961-124) , manufacture(42961-124) , pack(42961-124) , relabel(42961-124) , repack(42961-124)

Revised: 10/2018
 
Cintas