FDA.reportPublic FDA data

ADWE Regular Strength Antacid Chewable Tablets 100 Count

Manufacturer
Raritan Pharmaceuticals Inc
Effective date
2026-07-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-07-21 05:10:06

Label at a glance#

ProductFast Acting Heartburn Relief Peppermint Flavor
Active ingredientCALCIUM CARBONATE
Label structure8 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 older: chew 2-4 tablets as symptoms occur, or as directed by a doctor • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 500mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

Warnings

WARNINGS SECTION

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 15 tablets in 24 hours
  • if pregnant do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: chew 2-4 tablets as symptoms occur, or as directed by a doctor
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: elemental calcium 200mg
  • store at room temperature. Keep the container tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gum acacia, magnesium stearate, microcrystalline cellulose, natural peppermint oil, polyplasdone, sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68163-011-00

*COMPARE TO THE ACTIVE INGREDIENT IN REGULAR STRENGTH TUM®

FAST ACTING

HEARTBURN RELIEF

FOR FAST RELIEF OF:

ACID INDIGESTION, SOUR STOMACH & HEARTBURN

PEPPERMINT FLAVOR

GLUTEN FREE

100 CHEWABLE TABLETS

KOSHER FOR PASSOVER

This product does not contain any Chometz or Kitnius

This product contains no animal soybean, or grain derivatives.

Manufactured for: Adwe Laboratories

1274 49 Street, Brooklyn, NY 11219

*This product is not manufactured or distributed by GlaxoSmithKline LLC, the owner of the registered trademark Regular Strength Tums®.

Fast Acting Heartburn Relief Antacid 100 Chewable Tablets
Fast Acting Heartburn Relief Antacid 100 Chewable Tablets

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

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68163-01168163-011-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ACACIA5C5403N26OIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PEPPERMINT OILAV092KU4JHIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
SUCROSEC151H8M554IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-07-17full-release2026-06-01 01:07:36

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
Fast Acting Heartburn Relief Peppermint FlavorCALCIUM CARBONATERaritan Pharmaceuticals Inca7c5a5db-bdfe-4601-ae51-dedd81626b0d2026-07-17WarningsExact identifier
ndc (package): 68163-011-00
ndc (product): 68163-011
ndc11 (package): 68163001100
spl id: a988c415-e9eb-4008-a895-bac3021a0bc5
spl set id: a7c5a5db-bdfe-4601-ae51-dedd81626b0d

Reported adverse events (FAERS/openFDA)#

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