LEGEND PREMIUM HEARTBURN 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 GAS RELIEF CHEWABLE

Active Ingredients

Calcium carbonate 750 mg.

Simethicone 80 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
● bloating, pressure, or stuffed feeling commonly referred to as gas

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
● store at room temperature. Avoid excessive heat above 40oC (104 F).

Inactive Ingredients

Dextrose monohydrate, Saccharin sodium, Sucrose, Dokudami extract, FD&C Red No. 3, Povidone K30, Water, Xylitol, Sorbitol, Magnesium Stearate, Peppermint, Silicon Dioxide

Product Label

image description

LEGEND PREMIUM HEARTBURN CHEWABLE 
calcium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-844
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
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
ColorpinkScoreno score
ShapeROUNDSize2mm
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-844-2424 in 1 BOX; Type 0: Not a Combination Product06/22/2020
2NDC:13411-844-3030 in 1 BOX; Type 0: Not a Combination Product06/22/2020
3NDC:13411-844-6060 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: 5f42f4e8-29fa-4cf9-947b-48d8f75e8622
Set id: fc85cff6-3449-4f86-9afc-2653842d6d28
Version: 1
Effective Time: 20200622
 
ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS