Label: LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE- calcium carbonate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 13411-843-24, 13411-843-30, 13411-843-60 - Packager: ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 22, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredientsAsk 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 occurIf pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Uses for the relief of
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEGEND PREMIUM HEARTBURN RELIEF - EXTRA STRENGTH CHEWABLE
calcium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-843 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 750 mg Inactive Ingredients Ingredient Name Strength 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 Color blue Score no score Shape ROUND Size 2mm Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13411-843-24 24 in 1 BOX; Type 0: Not a Combination Product 06/22/2020 2 NDC:13411-843-30 30 in 1 BOX; Type 0: Not a Combination Product 06/22/2020 3 NDC:13411-843-60 60 in 1 BOX; Type 0: Not a Combination Product 06/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/22/2020 Labeler - ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS (187498279)