LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF- 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 CHEWABLE

Active Ingredient

Calcium carbonate 500 mg.

Purpose

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 2 to 3 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 200 mg
● store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Blue No. 1, FD&C yellow No. 5, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

Product Label

image description

LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-845
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION500 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)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
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
ColorgreenScoreno score
ShapeROUNDSize2mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-845-2424 in 1 BOX; Type 0: Not a Combination Product06/22/2020
2NDC:13411-845-3030 in 1 BOX; Type 0: Not a Combination Product06/22/2020
3NDC:13411-845-6060 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: 8d05f0e3-af49-40c6-998f-1064fc99efc2
Set id: a6184338-cd4a-42a3-8eb4-a91f16e37c7b
Version: 1
Effective Time: 20200622
 
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS