Calcium Carbonate 750mg

Calcium Carbonate 750mg
SPL v5
SPL
SPL Set ID d6a6315f-19ca-e760-e053-2a95a90a8311
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: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-24

Description

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


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 chewable tablets every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24-hours. Children under 12 years consult a doctor.

Description

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

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 50570-1

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

Section 51727-6

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, 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 to 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 750mg

Section 60561-8

Other information

  • Each chewable tablet contains: calcium 300mg
  • 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. Do not exceed 5 chewable tablets 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 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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, 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 to 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 750mg

Section 60561-8 (60561-8)

Other information

  • Each chewable tablet contains: calcium 300mg
  • 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

All Sections (JSON)