Calcium Carbonate Antacid Assorted Berries — v1

Calcium Carbonate Antacid Assorted Berries

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Version

v1

Effective date

September 22, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3f63fb7a-b446-1560-e063-6394a90adce8
Set ID
3f640ccd-4b8d-fc24-e063-6294a90a6e58
Application numbers
M001
Product NDCs
83698-361
Package NDCs
83698-361-16
Original packager NDCs
—

Names & Manufacturers

Brand names
Calcium Carbonate Antacid Assorted Berries
Generic names
CALCIUM CARBONATE
Manufacturer names
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
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
308915
UNII
H0G9379FGK
UPC
0810025928247

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Calcium carbonate 750 mg
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, 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 more than 2 weeks unless advised by a doctor.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients corn starch, FD&C Blue No.1, FD&C Red No. 40, flavors, magnesium stearate, maltitol, sucralose, sucrose
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.
Other Safety Information (1)

Sequence 1

Other information each tablet contains: calcium 300 mg store at room temperature (20-25°C (68-75°F)). Keep the container tightly closed. do not use if printed seal under cap is torn or missing
Package Label Principal Display Panel (1)

Sequence 1

image description
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use
Purpose (1)

Sequence 1

Purpose Antacid
Questions (1)

Sequence 1

Questions or comments? +1-866-306-9136 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM Eastern Time.
Spl Product Data Elements (1)

Sequence 1

Calcium Carbonate Antacid Assorted Berries Calcium Carbonate STARCH, CORN FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE MALTITOL SUCRALOSE SUCROSE CALCIUM CARBONATE CALCIUM CATION (Purple, red, pink)
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 10 tablets in 24 hours. do not use the maximum dosage of this product for more than 2 weeks except under advice and supervision of a doctor if pregnant do not take more than 5 tablets in 24 hours. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children.
When Using (1)

Sequence 1

When using this product do not take more than 10 tablets in 24 hours. do not use the maximum dosage of this product for more than 2 weeks except under advice and supervision of a doctor if pregnant do not take more than 5 tablets in 24 hours.

OpenFDA raw payload

{'application_number': ['M001'],
 'brand_name': ['Calcium Carbonate Antacid Assorted Berries'],
 'generic_name': ['CALCIUM CARBONATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Xiamen Kang Zhongyuan Biotechnology Co., Ltd.'],
 'package_ndc': ['83698-361-16'],
 'product_ndc': ['83698-361'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['308915'],
 'spl_id': ['3f63fb7a-b446-1560-e063-6394a90adce8'],
 'spl_set_id': ['3f640ccd-4b8d-fc24-e063-6294a90a6e58'],
 'substance_name': ['CALCIUM CARBONATE'],
 'unii': ['H0G9379FGK'],
 'upc': ['0810025928247']}