major regular strength antacid 150 chewable tablets

major regular strength antacid 150 chewable tablets
SPL v3
SPL
SPL Set ID af10dfb6-fef3-3410-e053-2995a90a9130
Route
oral
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calcium cation (500 mg)
Inactive Ingredients
adipic acid d&c red no. 27 d&c yellow no. 10 dextrose, unspecified form fd&c blue no. 1 fd&c yellow no. 6 magnesium stearate maltodextrin starch, corn sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP101 Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2014-08-12

Purpose

Antacid

Description

Calcium Carbonate USP 500mg


Medication Information

Warnings

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • If pregnant do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Purpose

Antacid

Directions
  • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
  • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
Other Information
  • each tablet contains: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive Ingredients

adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Description

Calcium Carbonate USP 500mg

Active Ingredient

Calcium Carbonate USP 500mg

Package/label Principal Display Panel


Structured Label Content

Warnings

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

When using this product

  • do not take more than 15 tablets in 24 hours
  • If pregnant do not take more than 10 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.
Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Purpose

Antacid

Directions
  • Adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
  • Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.
Other Information
  • each tablet contains: elemental calcium 200 mg
  • Store at room temperature. Keep the container tightly closed

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive Ingredients (Inactive ingredients)

adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Active Ingredient (Active ingredient)

Calcium Carbonate USP 500mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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