FDA.reportPublic FDA data

DRx CHOICE Regular Strength Antacid Tablets

Manufacturer
RARITAN PHARMACEUTICALS INC
Effective date
2026-09-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-08 02:02:27

Label at a glance#

ProductRegular Strength Tropical Fruit
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 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate USP 500 mg

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 before use if you are taking prescription drugs. 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

adipic acid, dextrose, FD&C Red No. 40, FD & C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions or comments

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRx CHOICE®

NDC# 68163-100-66

*Compare to the active ingredient in Regular Strength Tums®

REGULAR STRENGTH

Antacid Tablets

Calcium Carbonate 500 mg

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

Tropical Fruit

Naturally and Artificially Flavored

66 Chewable Tablets

GLUTEN-FREE

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court

East Brunswick, NJ 08816

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

DRx Extra Strength Antacid 66 Tablets
DRx Extra Strength Antacid 66 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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68163-10068163-100-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-09-26full-release2026-06-01 01:14:55

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
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
ndc (package): 68163-100-66
ndc (product): 68163-100
ndc11 (package): 68163010066
spl id: 407dc7a8-9be0-4c77-a47b-7eacb1986f46
spl set id: 38c6cece-71a0-40d8-bfc8-2f6467f9239b

Reported adverse events (FAERS/openFDA)#

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