calcium antacid

calcium antacid
SPL v3
SPL
SPL Set ID 6133b620-5fa5-404c-a800-3b042f6f0642
Route
oral
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calcium cation (500 mg)
Inactive Ingredients
acacia silicon dioxide d&c red no. 27 fd&c blue no. 1 magnesium stearate maltodextrin microcrystalline cellulose starch, corn sucrose

Identifiers & Packaging

Pill Appearance
Imprint: GPI;1 Shape: round Color: pink Color: white Color: blue Size: 16 mm Score: 1
Marketing Status
otc monograph final active Since 2006-03-27

Purpose

Antacid

How Supplied

Product: 50090-4478 NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC

Description

Calcium Carbonate, USP 500 mg


Medication Information

Warnings

Do not take more than 15 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.



Active Ingredient

Calcium Carbonate, USP 500 mg



Uses

for the relief of

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Purpose

Antacid



Directions

Adults and children 12 years and older

Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a doctor

Children under 12 years

Do not give to children under 12 years unless directed by a doctor

Other Information
  • Each tablet contains: Elemental Calcium 195 mg
  • Each tablet contains: Sugar 1g
  • Do not exceed recommended dosage
  • Store at room temperature in a dry place
  • Do not use if clear neck seal is broken or missing
Inactive Ingredients

Acacia, Artificial Cherry Flavor, Artificial Red Berry Flavor, Colloidal Silica, D and C Red #27 Lake, FD and C Blue #1 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and Artificial Spearmint Flavor, Strach, Sucrose



How Supplied

Product: 50090-4478

NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC

Description

Calcium Carbonate, USP 500 mg

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.



Calcium Carbonate
If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Structured Label Content

Warnings

Do not take more than 15 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.



Active Ingredient (Active ingredient (in each tablet))

Calcium Carbonate, USP 500 mg



Uses

for the relief of

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Purpose

Antacid



Directions

Adults and children 12 years and older

Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a doctor

Children under 12 years

Do not give to children under 12 years unless directed by a doctor

Other Information (Other information)
  • Each tablet contains: Elemental Calcium 195 mg
  • Each tablet contains: Sugar 1g
  • Do not exceed recommended dosage
  • Store at room temperature in a dry place
  • Do not use if clear neck seal is broken or missing
Inactive Ingredients (Inactive ingredients)

Acacia, Artificial Cherry Flavor, Artificial Red Berry Flavor, Colloidal Silica, D and C Red #27 Lake, FD and C Blue #1 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural and Artificial Spearmint Flavor, Strach, Sucrose



How Supplied (HOW SUPPLIED)

Product: 50090-4478

NDC: 50090-4478-0 150 TABLET, CHEWABLE in a BOTTLE, PLASTIC

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.



Calcium Carbonate (CALCIUM CARBONATE)
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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