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SPL v1
SPL
SPL Set ID 72dcce11-adce-432c-b199-aa1e4730d215
Route
oral
Published
Effective Date 2019-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calcium cation (500 mg)
Inactive Ingredients
adipic acid starch, corn crospovidone, unspecified d&c red no. 27 aluminum lake d&c red no. 30 d&c yellow no. 10 dextrose monohydrate fd&c yellow no. 6 magnesium palmitostearate maltodextrin sucrose talc

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-03-29
Purpose

Antacid

Description

Calcium Carbonate 500mg

Medication Information

Active Ingredient

Calcium Carbonate 500mg

Purpose

Antacid

Directions

• adults and children 12 years of age and over:

chew 2 - 4 tablets as symptoms occur, or as directed by doctor.

Other Information
  • each tablet contains: elemental calcium 200mg
  • store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients

adipic acid, corn starch, crospovidone, D&C red #27 lake, D&C red #30 lake, D&C yellow #10 lake, dextrose, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Description

Calcium Carbonate 500mg

Uses:

• relieves  

  • acid indigestion. 

  • heartburn.

Section 42229-5

NDC: 73006-118-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Section 50565-1

Keep out of reach of children.

Packaging

Warnings:

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Do not use

  • 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.

  • May cause constipation.
  • May have laxative effect.

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

Drug Fatcs

Questions Or Comments ?

1-833-665-9444.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Calcium Carbonate 500mg

Purpose

Antacid

Directions

• adults and children 12 years of age and over:

chew 2 - 4 tablets as symptoms occur, or as directed by doctor.

Other Information
  • each tablet contains: elemental calcium 200mg
  • store at room temperature between 20-25°C (68-77°F).
Inactive Ingredients

adipic acid, corn starch, crospovidone, D&C red #27 lake, D&C red #30 lake, D&C yellow #10 lake, dextrose, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

Uses:

• relieves  

  • acid indigestion. 

  • heartburn.

Section 42229-5 (42229-5)

NDC: 73006-118-41

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Section 50565-1 (50565-1)

Keep out of reach of children.

Packaging

Warnings:

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Do not use

  • 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.

  • May cause constipation.
  • May have laxative effect.

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

Drug Fatcs (DRUG FATCS)

Questions Or Comments ?

1-833-665-9444.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:48.646553 · Updated: 2026-03-14T22:55:31.631898