Calcium Carbonate 750 Mg

Calcium Carbonate 750 Mg
SPL v1
SPL
SPL Set ID 45f6b593-a09c-ce0b-e063-6394a90ae307
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: FC Shape: round Color: orange Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Active ingredient (in each chewable tablet) Calcium carbonate 750 mg


Medication Information

Warnings and Precautions

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Do not take more 5 chewable tablets in a 24-hour period, or use the maximum dosage for this product for more than 2 weeks, except under the advice and supervision of a physician.

Indications and Usage

Uses Relieves

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Upset stomach due to these symptoms
Dosage and Administration

Directions

Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed.

Children under 12 years consult a doctor.

Description

Active ingredient (in each chewable tablet) Calcium carbonate 750 mg

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product constipation may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients: Beeswax, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, phosphoric acid, pregelantinized corn starch, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide.

Section 51945-4

Section 53413-1

Questions? Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antacid

Section 55106-9

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Section 60561-8

Other information

  • Each chewable tablet contains: calcium 300 mg
  • Contains soy
  • Contains FD&C yellow No. 5 (tartrazine) as a color additive
  • Store between 20° to 25°C (68° to 77°F) in a dry place

Structured Label Content

Indications and Usage (34067-9)

Uses Relieves

  • Heartburn
  • Sour stomach
  • Acid indigestion
  • Upset stomach due to these symptoms
Dosage and Administration (34068-7)

Directions

Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed.

Children under 12 years consult a doctor.

Warnings and Precautions (34071-1)

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Do not take more 5 chewable tablets in a 24-hour period, or use the maximum dosage for this product for more than 2 weeks, except under the advice and supervision of a physician.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product constipation may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Inactive ingredients: Beeswax, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, phosphoric acid, pregelantinized corn starch, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Or to report an adverse event call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antacid

Section 55106-9 (55106-9)

Active ingredient (in each chewable tablet)

Calcium carbonate 750 mg

Section 60561-8 (60561-8)

Other information

  • Each chewable tablet contains: calcium 300 mg
  • Contains soy
  • Contains FD&C yellow No. 5 (tartrazine) as a color additive
  • Store between 20° to 25°C (68° to 77°F) in a dry place

Advanced Ingredient Data


Raw Label Data

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