Calcium Carbonate 750 Mg

Calcium Carbonate 750 Mg
SPL v8
SPL
SPL Set ID 47e0830f-31e7-5ff0-e054-00144ff88e88
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 Color: pink Color: yellow Size: 22 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-30

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.

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 chews every 2-4 hours as needed. Do not exceed 5 chews in 24 hours. 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 50569-3

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

Section 50570-1

Do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

When using this product constipation may occur.

Section 51727-6

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, and 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, magnesium 1 mg
  • Contains Soy
  • Contains yellow no. 5 (tartrazine) as a color additive
  • Store between 20º to 25ºC (68º to 77ºF) 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 chews every 2-4 hours as needed. Do not exceed 5 chews in 24 hours. 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

When using this product constipation may occur.

Section 51727-6 (51727-6)

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose, and 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, magnesium 1 mg
  • Contains Soy
  • Contains yellow no. 5 (tartrazine) as a color additive
  • Store between 20º to 25ºC (68º to 77ºF) in a dry place

Advanced Ingredient Data


Raw Label Data

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