Nutralox - DailyMed Details

Nutralox

SPL v3

SPL

SPL Set ID 263e20ca-1ca6-4f7c-bae5-525a1184b744

Route

ORAL

Published

Effective Date 2020-06-05

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 FINAL Active Since 1987-01-20

Description

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

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

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 51945-4

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

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 51945-4 (51945-4)

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

Advanced Ingredient Data

[{"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "420", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Temporarily relieves heartburn sour stomach acid indigestion upset stomach", "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", "34071-1": "Warnings:", "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", "50566-9": "Stop use and ask a doctor if symptoms last for more than 2 weeks", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interfere with certain prescription drugs.", "51727-6": "Inactive Ingredients : Acacia Gum, Flavor, Magnesium Stearate, Maltodextrin, Silicon Dioxide, Starch, Sucrose", "53414-9": "If pregnant or breast-feeding , ask a health professional before use", "55105-1": "Purpose: Antacid", "55106-9": "Active Ingredient (in each tablet): Calcium Carbonate 420 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:48.952837 · Updated: 2026-03-14T22:57:05.210150