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SPL v1

SPL

SPL Set ID 7b36ad70-b84a-244f-e053-2991aa0a7314

Route

ORAL

Published

Effective Date 2018-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Aluminum Phosphate (12.38 g) Hydroxide Ion (400 mg) Dimethicone (40 mg)

Inactive Ingredients

Pectin Water Agar

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-11-15

Description

Aluminum Phosphate, Colloidal Magnesium Hydroxide Simethicone

Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs

When using this product

■ Do not take more than 4 envelop in 24 hours

■ Do not use the maximum dosage for more than 2 weeks

Indications and Usage

■ take 2-3 envelops as symptoms accur, as directed by a doctor

Dosage and Administration

For oral use only

Description

Aluminum Phosphate, Colloidal Magnesium Hydroxide Simethicone

Section 50565-1

Keep out of reach of children

Section 51727-6

water, sugar, agar, pectin, essence of orange, calcium

Section 51945-4

Section 55105-1

■ sour stomach ■ acid indigestion ■ upset stomach associated with these

Section 55106-9

Aluminum Phosphate, Colloidal

Magnesium Hydroxide

Simethicone

Structured Label Content

Indications and Usage (34067-9)

■ take 2-3 envelops as symptoms accur, as directed by a doctor

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs

When using this product

■ Do not take more than 4 envelop in 24 hours

■ Do not use the maximum dosage for more than 2 weeks

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

water, sugar, agar, pectin, essence of orange, calcium

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ sour stomach ■ acid indigestion ■ upset stomach associated with these

Section 55106-9 (55106-9)

Aluminum Phosphate, Colloidal

Magnesium Hydroxide

Simethicone

Advanced Ingredient Data

[{"name": "PECTIN", "unii": "89NA02M4RX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM PHOSPHATE", "unii": "F92V3S521O", "classCode": "ACTIB", "strengthNumerator": "12.38", "strengthDenominator": "20", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AGAR", "unii": "89T13OHQ2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "■ take 2-3 envelops as symptoms accur, as directed by a doctor", "34068-7": "For oral use only", "34071-1": "Warnings Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs When using this product ■ Do not take more than 4 envelop in 24 hours ■ Do not use the maximum dosage for more than 2 weeks", "50565-1": "Keep out of reach of children", "51727-6": "water, sugar, agar, pectin, essence of orange, calcium", "55105-1": "■ sour stomach ■ acid indigestion ■ upset stomach associated with these", "55106-9": "Aluminum Phosphate, Colloidal Magnesium Hydroxide Simethicone"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:40.999705 · Updated: 2026-03-14T22:55:19.604592