Regular Strength Tropical Fruit — v7

Regular Strength Tropical Fruit

7 Views

Version

v7

Effective date

September 26, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
3fb163d7-56d1-0fd7-e063-6394a90a38a6
Set ID
38c6cece-71a0-40d8-bfc8-2f6467f9239b
Application numbers
M001
Product NDCs
68163-100
Package NDCs
68163-100-66
Original packager NDCs
—

Names & Manufacturers

Brand names
Regular Strength Tropical Fruit
Generic names
CALCIUM CARBONATE
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
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (per tablet) Calcium Carbonate USP 500 mg
Dosage And Administration (1)

Sequence 1

Directions 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.
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients adipic acid, dextrose, FD&C Red No. 40, FD & C Yellow No. 6, flavor, 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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Package Label Principal Display Panel (1)

Sequence 1

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
Purpose (1)

Sequence 1

Purpose Antacid
Questions (1)

Sequence 1

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

Sequence 1

Regular Strength Tropical Fruit Calcium Carbonate ADIPIC ACID DEXTROSE, UNSPECIFIED FORM FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE CALCIUM CARBONATE CALCIUM CATION CARBONATE ION RP101
Storage And Handling (1)

Sequence 1

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

Sequence 1

Warnings 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 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.

OpenFDA raw payload

{'application_number': ['M001'],
 'brand_name': ['Regular Strength Tropical Fruit'],
 'generic_name': ['CALCIUM CARBONATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['RARITAN PHARMACEUTICALS INC'],
 'package_ndc': ['68163-100-66'],
 'product_ndc': ['68163-100'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['308907'],
 'spl_id': ['3fb163d7-56d1-0fd7-e063-6394a90a38a6'],
 'spl_set_id': ['38c6cece-71a0-40d8-bfc8-2f6467f9239b'],
 'substance_name': ['CALCIUM CARBONATE'],
 'unii': ['H0G9379FGK']}