Calcium Carbonate 750mg

Calcium Carbonate 750mg
SPL v1
SPL
SPL Set ID 2bd244bb-bf8f-2c71-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg)
Inactive Ingredients
Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: AS Shape: round Color: yellow Color: pink Color: orange Size: 70 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-08-31

Description

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 for the relief of:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Dosage and Administration

Directions

  • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
  • children under 12 years: consult a doctor
  • do not take more than 5 chewable tablets in a 24-hour period

Description

Calcium Carbonate 750mg

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

  • do not take more than 5 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the adivce and supervision of a physician.
  • constipation may occur

Section 50568-5

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

Section 51727-6

Inactive Ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 (tartrazine), FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methly paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

Section 51945-4

Section 53413-1

Questions or comments?

1-800-986-0369 (Mon-Fri 9am-5pm EST)

Section 53414-9

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

Section 55105-1

Purpose

Antacid

Section 55106-9

Calcium Carbonate 750mg

Section 60561-8

Other information

  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No.5 (tartrazine) as a color additive
  • store at room temperature. Avoid humiditity.
  • close cap tightly after use.

Structured Label Content

Indications and Usage (34067-9)

Uses for the relief of:

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
  • children under 12 years: consult a doctor
  • do not take more than 5 chewable tablets in a 24-hour period

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

  • do not take more than 5 chewable tablets in a 24-hour period
  • do not use the maximum dosage of this product for more than 2 weeks except under the adivce and supervision of a physician.
  • constipation may occur

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

Inactive Ingredients

acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 (tartrazine), FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methly paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-986-0369 (Mon-Fri 9am-5pm 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)

Calcium Carbonate 750mg

Section 60561-8 (60561-8)

Other information

  • each chewable tablet contains: calcium 300 mg
  • contains FD&C Yellow No.5 (tartrazine) as a color additive
  • store at room temperature. Avoid humiditity.
  • close cap tightly after use.

Advanced Ingredient Data


Raw Label Data

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