DRx CHOICE Antacid Calcium Regular Strength — v9

DRx CHOICE Antacid Calcium Regular Strength

4 Views

Version

v9

Effective date

September 26, 2025

Original packager

Yes

Sections captured

13

Identifiers

Document ID
3fb14c80-fc45-2727-e063-6394a90a3f25
Set ID
0c579405-9397-4bf2-8441-e89011b19ec4
Application numbers
M001
Product NDCs
68163-101
Package NDCs
68163-101-12, 68163-101-50
Original packager NDCs
—

Names & Manufacturers

Brand names
DRx CHOICE Antacid Calcium Regular Strength
Generic names
CALCIUM CARBONATE 500MG
Manufacturer names
Raritan Pharmaceuticals Inc
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
CALCIUM CARBONATE
Routes
ORAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
308907
UNII
H0G9379FGK
UPC
0368163101256

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (per tablet) Calcium Carbonate USP 500mg
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Dosage And Administration (1)

Sequence 1

Directions adults and children 12 years of age and over: chew 2-4 tablets 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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients adipic acid, D&C Red No. 27, D&C Yellow No. 10 dextrose, FD&C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, sucralose.
Indications And Usage (1)

Sequence 1

Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel DRx CHOICE ® *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. Assorted Fruit Naturally & Artificially Flavored GLUTEN-FREE Chewable Tablets 60 K PAREVE DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums ® . Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 Package label for 60ct Tablets DRx Choice Assorted Fruit Antacid 60 CT

Sequence 2

Principal Display Panel Package label for 150ct Tablets DRx Choice R/S Antacid Tablets Assorted Fruit Flavor 150ct
Purpose (1)

Sequence 1

Purpose Antacid
Questions (1)

Sequence 1

Questions? 1-866-467-2748
Spl Product Data Elements (1)

Sequence 1

DRx CHOICE Antacid Calcium Regular Strength Calcium Carbonate 500mg ADIPIC ACID D&C RED NO. 27 D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE CALCIUM CARBONATE CARBONATE ION CALCIUM CATION RP101 assorted
Storage And Handling (1)

Sequence 1

Other information each tablet contains: elemental calcium 200mg store at room temperature. Keep the container tightly closed.
Warnings (1)

Sequence 1

Warnings 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 Keep out of reach of children.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M001'],
 'brand_name': ['DRx CHOICE Antacid Calcium Regular Strength'],
 'generic_name': ['CALCIUM CARBONATE 500MG'],
 'is_original_packager': [True],
 'manufacturer_name': ['Raritan Pharmaceuticals Inc'],
 'package_ndc': ['68163-101-12', '68163-101-50'],
 'product_ndc': ['68163-101'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['308907'],
 'spl_id': ['3fb14c80-fc45-2727-e063-6394a90a3f25'],
 'spl_set_id': ['0c579405-9397-4bf2-8441-e89011b19ec4'],
 'substance_name': ['CALCIUM CARBONATE'],
 'unii': ['H0G9379FGK'],
 'upc': ['0368163101256']}