Calcium Carbonate 750 Mg

Calcium Carbonate 750 Mg
SPL v1
SPL
SPL Set ID 2be4bf9d-9f5c-2277-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: FC Shape: round Color: yellow Color: pink Color: orange Size: 70 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-03-23

Description

Active Ingredient (in each chew) 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 than 5 chews in a 24 hour period, or use the maxiumum dosage 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 year sand 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 chew) 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, carmine, carnauba wax, citric acid, 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, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide. Soybean oil and corn starch are used as processing aids.

Section 51945-4

Section 53413-1

Questions?

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 chew)

Calcium carbonate 750 mg

Section 60561-8

Other information

  • Each chew contains: calcium 300mg, magnesium 1mg
  • Contains soy
  • 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 year sand 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.

Do not take more than 5 chews in a 24 hour period, or use the maxiumum dosage 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, carmine, carnauba wax, citric acid, 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, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide. Soybean oil and corn starch are used as processing aids.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

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 chew)

Calcium carbonate 750 mg

Section 60561-8 (60561-8)

Other information

  • Each chew contains: calcium 300mg, magnesium 1mg
  • Contains soy
  • Store between 20 to 25 C (68 to 77 F) in a dry place

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)