Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID ee1374c6-b7e7-42e4-84ee-452661b0d979

Route

ORAL

Published

Effective Date 2018-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Aluminum Hydroxide (400 mg) Hydroxide Ion (40 mg) Dimethicone

Inactive Ingredients

Hypromelloses Butylparaben Saccharin Sodium Hypochlorite Sorbitol Propylparaben Water Xanthan Gum Lemon Oil

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH FINAL Active Since 1999-03-16

Description

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg Magnesium Hydroxide 400 mg Simethicone 40 mg

Purpose

Antacid Antigas

Medication Information

Purpose

Antacid

Antigas

Description

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg Magnesium Hydroxide 400 mg Simethicone 40 mg

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
associated symptoms of gas and upset stomach
•
overindulgence of food and drink

Directions

•
shake well before each use
•
adults and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
•
do not take more than 12 teaspoonsful in 24 hour period
•
do not use the maximum dosage for more than 2 weeks
•
children under 12 years: ask a doctor

Other Information

•
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
•
Store at room temperature 15º - 30ºC (59º - 86ºF)
•
keep tightly closed
•
protect from freezing
•
each teaspoon (5 mL) contains: magnesium 165 mg
•
each teaspoon (5 mL) contains: sodium 1 mg
•
does not meet USP requirements for preservative effectiveness

Inactive Ingredients

flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, xanthan gum and water

Principal Display Panel

Stop Use and Ask A Doctor If

symptoms last for more than 2 weeks

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have

•
kidney disease
•
a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

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

Active Ingredients (in Each 5 Ml) (one Teaspoonful)

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 mg

Structured Label Content

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
associated symptoms of gas and upset stomach
•
overindulgence of food and drink

Purpose

Antacid

Antigas

Directions

•
shake well before each use
•
adults and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician
•
do not take more than 12 teaspoonsful in 24 hour period
•
do not use the maximum dosage for more than 2 weeks
•
children under 12 years: ask a doctor

Other Information (Other information)

•
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
•
Store at room temperature 15º - 30ºC (59º - 86ºF)
•
keep tightly closed
•
protect from freezing
•
each teaspoon (5 mL) contains: magnesium 165 mg
•
each teaspoon (5 mL) contains: sodium 1 mg
•
does not meet USP requirements for preservative effectiveness

Inactive Ingredients (Inactive ingredients)

flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, xanthan gum and water

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms last for more than 2 weeks

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
kidney disease
•
a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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

Active Ingredients (in Each 5 Ml) (one Teaspoonful) (Active ingredients (in each 5 mL) (One teaspoonful))

Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg

Magnesium Hydroxide 400 mg

Simethicone 40 mg

Advanced Ingredient Data

[{"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROXIDE ION", "unii": "9159UV381P", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN", "unii": "FST467XS7D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYPOCHLORITE", "unii": "DY38VHM5OD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON OIL", "unii": "I9GRO824LL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves • heartburn • acid indigestion • sour stomach • associated symptoms of gas and upset stomach • overindulgence of food and drink", "Purpose": "Antacid Antigas", "Directions": "• shake well before each use • adults and children 12 years, take 2 - 4 teaspoonsful between meals, at bedtime or as directed by a physician • do not take more than 12 teaspoonsful in 24 hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor", "Other information": "• TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING. • Store at room temperature 15º - 30ºC (59º - 86ºF) • keep tightly closed • protect from freezing • each teaspoon (5 mL) contains: magnesium 165 mg • each teaspoon (5 mL) contains: sodium 1 mg • does not meet USP requirements for preservative effectiveness", "Inactive ingredients": "flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, xanthan gum and water", "Stop use and ask a doctor if": "symptoms last for more than 2 weeks", "Keep out of reach of children.": "In case of accidental overdose, get medical help or contact a Poison Control Center immediately.", "Ask a doctor before use if you have": "• kidney disease • a magnesium-restricted diet", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug. Antacids may interact with certain prescription drugs.", "Active ingredients (in each 5 mL) (One teaspoonful)": "Aluminum Hydroxide (Equi. to Dried Gel, USP) 400 mg Magnesium Hydroxide 400 mg Simethicone 40 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:33.725605 · Updated: 2026-03-14T22:55:06.338046