LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE- calcium carbonate tablet 
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS

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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LEGEND PREMIUM HEARTBURN RELIEF-EXTRA STRENGTH CHEWABLE

Active Ingredient

Calcium carbonate 750 mg

Purpose

Antacid

Warnings


Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product.
● Do not take more than 5 chewable tablets in a 24-hour period
● Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
● Constipation may occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Uses for the relief of


● acid indigestion.

● heartburn.

● sour stomach.

● upset stomach associated with these symptoms.

Directions

● adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
● children under 12 years: consult a doctor.
● do not take more than 5 chewable tablets in a 24-hour period.

Other information

● each chewable tablet contains: calcium 300 mg.
● contains FD&C Blue No. 1 as a color additive.
● store at room temperature. Avoid humidity.

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

image description

LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-843
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
SORBITOL (UNII: 506T60A25R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PEPPERMINT (UNII: V95R5KMY2B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize2mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-843-2424 in 1 BOX; Type 0: Not a Combination Product06/22/2020
2NDC:13411-843-3030 in 1 BOX; Type 0: Not a Combination Product06/22/2020
3NDC:13411-843-6060 in 1 BOX; Type 0: Not a Combination Product06/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/22/2020
Labeler - ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS (187498279)

Revised: 6/2020
Document Id: 9745e6c6-cba8-4238-b344-5821a2939fa4
Set id: 8601a194-fdf1-4a33-854e-153a7a2c578e
Version: 1
Effective Time: 20200622
 
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS