Indications and uses
● acid indigestion ● heartburn ● sour stomach ● upset stomach associated with these symptoms
LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF
- Manufacturer
- ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS
- Effective date
- 2020-06-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:19:29
Label at a glance#
ProductLEGEND PREMIUM HEARTBURN CHEWABLE RELIEF
Active ingredientCALCIUM CARBONATE
Label structure8 sections
Dosage and administration
● 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.
Label contents#
Full prescribing information#
Active Ingredient
Calcium carbonate 500 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.
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bee4fa8d-8d82-423a-a0b5-40a89dd13a99 | Product name | 1 | 20250618 |
| e0d2eb29-08bd-4bba-90d1-c91c68a38767 | Product name | 4 | 20250516 |
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| e92765c1-be81-432a-b909-1b10777ec378 | Product name | 1 | 20190208 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13411-845-24 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5be3-a426-e053-dadaa90af4c2 | LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE |
| 13411-845-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5be3-a426-e053-dadaa90af4c2 | LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE |
| 13411-845-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5be3-a426-e053-dadaa90af4c2 | LEGEND PREMIUM HEARTBURN RELIEF CHEWABLE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13411-845-24 | LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF | 24 in 1 BOX | TABLET | 24 | 1 | |
| 13411-845-30 | LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF | 30 in 1 BOX | TABLET | 30 | 1 | |
| 13411-845-60 | LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF | 60 in 1 BOX | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13411-845 | LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF (CALCIUM CARBONATE) TABLET [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS] | 1 | Legacy NDC, 3 package rows | 20200630_a6184338-cd4a-42a3-8eb4-a91f16e37c7b.zip |
Products#
Every source-derived product name is available through these pages.
- LEGEND PREMIUM HEARTBURN CHEWABLE RELIEF
- CALCIUM CARBONATE
- CALCIUM CATION
- DEXTROSE MONOHYDRATE
- SACCHARIN SODIUM
- SUCROSE
- HOUTTUYNIA CORDATA FLOWERING TOP
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 5
- POVIDONE K30
- WATER
- XYLITOL
- SORBITOL
- MAGNESIUM STEARATE
- PEPPERMINT
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13411-845 | 13411-845-24, 13411-845-30, 13411-845-60 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CALCIUM CARBONATE | H0G9379FGK | ACTIM |
| DEXTROSE MONOHYDRATE | LX22YL083G | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SUCROSE | C151H8M554 | IACT |
| HOUTTUYNIA CORDATA FLOWERING TOP | RH041UUZ22 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SORBITOL | 506T60A25R | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| PEPPERMINT | V95R5KMY2B | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 8d05f0e3-af49-40c6-998f-1064fc99efc2 | a6184338-cd4a-42a3-8eb4-a91f16e37c7b | 2020-06-22 | Warnings | 8d05f0e3-af49-40c6-998f-1064fc99efc2 a6184338-cd4a-42a3-8eb4-a91f16e37c7b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.