FDA.reportPublic FDA data

Ultra Strength Antacid Wintergreen Flavor

Manufacturer
7-ELEVEN | Medical Group Care LLC
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:26

Label at a glance#

ProductUltra Strength Antacid Wintergreen Flavor
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Indications and uses

Relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

Adults and children 12 years of age and over: chew 2-3 tablets, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow tablets whole. Do not take for symptoms that persist for mare than 2 weeks unless advised by a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 1000 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

WARNINGS SECTION

Warnings

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain perscription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 8 tablets in 24 hours
  • do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
  • if pregnant do not take more than 4 tablets in 24 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: chew 2-3 tablets, completely as symptoms occur, 2 times daily or as directed by a doctor. Do not swallow tablets whole.
  • Do not take for symptoms that persist for mare than 2 weeks unless advised by a doctor

Other information

OTHER SAFETY INFORMATION

  • Each tablet contains:calcium 400 mg
  • Store at room temperatrue (68-75ºF (20-25ºC)). Keep container tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C Blue No. 1 alluminum lake,FD&C Yellow No. 5 alluminum lake, flavors, magnesium stearate, maltitol, sucralose, sucrose

OTC - QUESTIONS SECTION

Questions?Call 1-800-255-0711

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN1
308892calcium carbonate 1000 MG Chewable TabletSCD1
308892calcium carbonate 1000 MG (calcium 400 MG) Chewable TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10202-010-12Ultra Strength Antacid Wintergreen Flavor12 in 1 PACKAGETABLET, CHEWABLE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10202-010ULTRA STRENGTH ANTACID WINTERGREEN FLAVOR (CALCIUM CARBONATE) TABLET, CHEWABLE [7-ELEVEN]1Current NDC, 1 package rows20250303_2f3c4e78-71d2-c46c-e063-6394a90a210a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10202-01010202-010-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
SUCRALOSE96K6UQ3ZD4IACT
MALTITOLD65DG142WKIACT
SUCROSEC151H8M554IACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
CALCIUM CARBONATEH0G9379FGKACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Strength Antacid Wintergreen FlavorCALCIUM CARBONATE7-ELEVEN2f3c4e78-71d2-c46c-e063-6394a90a210a2025-02-28WarningsExact identifier
ndc (package): 10202-010-12
ndc (product): 10202-010
ndc11 (package): 10202001012
spl id: 2f3c4e81-1692-cb9f-e063-6394a90a4a0d
spl set id: 2f3c4e78-71d2-c46c-e063-6394a90a210a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.