Nutralox

Nutralox
SPL v11
SPL
SPL Set ID 524e26a9-c69f-4e25-b83d-f4c65adca83d
Route
ORAL
Published
Effective Date 2024-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (420 mg)
Inactive Ingredients
Magnesium Stearate Sucrose Acacia Maltodextrin Silicon Dioxide Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1987-01-20
Description

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

How Supplied

Product: 50090-2440 NDC: 50090-2440-0 2 TABLET, CHEWABLE in a PACKET / 250 in a BOX, UNIT-DOSE

Medication Information

Warnings and Precautions

Warnings:

Indications and Usage

Uses: Temporarily relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach
Dosage and Administration

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

  • thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur
  • do not take more than 16 tablets in 24 hours unless directed by a doctor
  • do not use the maximum dose for more than 2 weeks

Children under 12 years of age: ask a doctor

How Supplied

Product: 50090-2440

NDC: 50090-2440-0 2 TABLET, CHEWABLE in a PACKET / 250 in a BOX, UNIT-DOSE

Description

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if symptoms last for more than 2 weeks

Section 50568-5

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

Section 51727-6

Inactive Ingredients: Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose

Section 53414-9

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

Section 55105-1

Purpose: Antacid

Section 55106-9

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

Calcium Carbonate

Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach
Dosage and Administration (34068-7)

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

  • thoroughly chew 2 tablets every 3 to 4 hours as symptoms occur
  • do not take more than 16 tablets in 24 hours unless directed by a doctor
  • do not use the maximum dose for more than 2 weeks

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings:

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms last for more than 2 weeks

Section 50568-5 (50568-5)

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

Section 51727-6 (51727-6)

Inactive Ingredients: Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose

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)

Active Ingredient (in each tablet): Calcium Carbonate 420 mg

How Supplied (HOW SUPPLIED)

Product: 50090-2440

NDC: 50090-2440-0 2 TABLET, CHEWABLE in a PACKET / 250 in a BOX, UNIT-DOSE

Calcium Carbonate (CALCIUM CARBONATE)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.733387 · Updated: 2026-03-14T23:03:59.769884