Calcium Carbonate 750mg

Calcium Carbonate 750mg
SPL v1
SPL
SPL Set ID 2bd3f180-802b-169e-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (750 mg) Dimethicone (80 mg)
Inactive Ingredients
Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: AS Shape: round Color: pink Size: 70 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-10-02

Description

Active Ingredients (in each chewable tablet) Calcium Carbonate 750mg Simethicone 80mg


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
  • bloating, pressure, or stuffed feeling commonly referred to as gas
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

Active Ingredients (in each chewable tablet) Calcium Carbonate 750mg Simethicone 80mg

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 advice 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, FD&C red #40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methly paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glyclol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, 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

Antigas

Section 55106-9

Active Ingredients

(in each chewable tablet)

Calcium Carbonate 750mg

Simethicone 80mg

Section 60561-8

Other information

  • each chewable tablet contains: calcium 330mg
  • store at room temperature. Avoid excessive heat above 40C (104F).
  • 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
  • bloating, pressure, or stuffed feeling commonly referred to as gas
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 advice 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, FD&C red #40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methly paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glyclol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, 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

Antigas

Section 55106-9 (55106-9)

Active Ingredients

(in each chewable tablet)

Calcium Carbonate 750mg

Simethicone 80mg

Section 60561-8 (60561-8)

Other information

  • each chewable tablet contains: calcium 330mg
  • store at room temperature. Avoid excessive heat above 40C (104F).
  • close cap tightly after use

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)