MAGNACAL- calcium carbonate tablet, chewable 
Afassco 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.

----------

ACTIVE INGREDIENT IN EACH TABLET- CALCIUM CARBONATE 420 MG

ANTACID

Uses: For the relief of the following symptoms associated with:

• acid indigestion • sour stomach

• heartburn • upset stomach

Warnings:

Ask a doctor or health professional before use if you are:

• taking a prescription drug. Antacids may interact with certain prescription drugs.

• do not use a maximum dosage for more than 2 weeks except under the advice of a physician.

If pregnant or breast-feeding baby, 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Adults and children: (12 years and older) 2 or more tablets chewed not to exceed18 tablets in a 24 hour period

Children: (under 12 years) Do not give to children under 12 years of age unless directed by a doctor.

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Other Information:

Each tablet contains: 168 mg of elemental calcium.

AfasscoMagnacal12-16

res

MAGNACAL 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINT (UNII: FV98Z8GITP)  
ACACIA (UNII: 5C5403N26O)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeROUNDSize12mm
FlavorMINTImprint Code FR8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-0303-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/07/2015
Labeler - Afassco Inc. (609982723)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(51532-0303)
Establishment
NameAddressID/FEIBusiness Operations
ULTRATAB LABORATORIES, INC.151051757manufacture(51532-0303)

Revised: 9/2019
Document Id: c8096db5-a27f-4fbe-a0c5-bce1ad91680a
Set id: 905fcd7a-7d39-448e-8301-3b931ae3ad41
Version: 3
Effective Time: 20190921
 
Afassco Inc.