Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID a21a94c5-7981-4cf9-af23-fc397b7ded1c

Route

ORAL

Published

Effective Date 2018-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Aluminum Hydroxide (225 mg) Hydroxide Ion (200 mg) Dimethicone (25 mg)

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) 225 mg Magnesium Hydroxide 200 mg Simethicone 25 mg

Purpose

Antacid Antigas

Medication Information

Purpose

Antacid

Antigas

Description

Aluminum Hydroxide (Equi. to Dried Gel, USP) 225 mg Magnesium Hydroxide 200 mg Simethicone 25 mg

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
associated symptoms of gas and upset stomach
•
pressure and bloating commonly referred to as gas

Warnings

Do not take more than 12 teaspoonfuls in a 24-hour period or use the maximum dosgae for more than 2 weeks. Except under the advise and supervision of a physician.

Directions

•
shake well before each use
•
Adults and children 12 years and older, take 2 to 4 teaspoonsful between meals, at bedtime or as directed by a physician
•
do not take more than 12 teaspoonsful in 24 or use the maximum dosage for more than 2 weeks
•
Children under 12 years: consult a physician

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 83 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, water and xanthan gum

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) 225 mg

Magnesium Hydroxide 200 mg

Simethicone 25 mg

Structured Label Content

Uses

relieves

•
heartburn
•
acid indigestion
•
sour stomach
•
associated symptoms of gas and upset stomach
•
pressure and bloating commonly referred to as gas

Purpose

Antacid

Antigas

Warnings

Do not take more than 12 teaspoonfuls in a 24-hour period or use the maximum dosgae for more than 2 weeks. Except under the advise and supervision of a physician.

Directions

•
shake well before each use
•
Adults and children 12 years and older, take 2 to 4 teaspoonsful between meals, at bedtime or as directed by a physician
•
do not take more than 12 teaspoonsful in 24 or use the maximum dosage for more than 2 weeks
•
Children under 12 years: consult a physician

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 83 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, water and xanthan gum

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) 225 mg

Magnesium Hydroxide 200 mg

Simethicone 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves • heartburn • acid indigestion • sour stomach • associated symptoms of gas and upset stomach • pressure and bloating commonly referred to as gas", "Purpose": "Antacid Antigas", "Warnings": "Do not take more than 12 teaspoonfuls in a 24-hour period or use the maximum dosgae for more than 2 weeks. Except under the advise and supervision of a physician.", "Directions": "• shake well before each use • Adults and children 12 years and older, take 2 to 4 teaspoonsful between meals, at bedtime or as directed by a physician • do not take more than 12 teaspoonsful in 24 or use the maximum dosage for more than 2 weeks • Children under 12 years: consult a physician", "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 83 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, water and xanthan gum", "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) 225 mg Magnesium Hydroxide 200 mg Simethicone 25 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:33.683616 · Updated: 2026-03-14T22:55:06.338046