SPL v2
SPL
SPL Set ID cd711cb3-293b-42f1-a853-ab02d2054e4e
Route
ORAL
Published
Effective Date 2013-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (200 mg) Hydroxide Ion (20 mg) Dimethicone
Inactive Ingredients
Benzyl Alcohol Butylparaben Carboxymethylcellulose Sodium Hypromelloses Cellulose, Microcrystalline Propylparaben Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-01
Description

Aluminum hydroxide 200 mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg

Purpose

Antacid Antigas

Medication Information

Purpose

Antacid Antigas

Description

Aluminum hydroxide 200 mg (equivalent to dried gel, USP) Magnesium hydroxide 200 mg Simethicone 20mg

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas
Section 50565-1

Keep out of reach of children.

Section 51945-4
Purposes

Antacid

Antigas

Warnings

Ask a doctor before use if you have

• kidney disease

• a magnesium-restricted diet

taking a prescription drug. Ask a doctor or pharmacist before use if you are

Antacids may interact with certain prescription drugs.

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

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

Directions

• shake well before use

• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• children under 12 years: ask a doctor

Other Information

• magnesium 85 mg, sodium 1 mg each 5 mL teaspoonful contains:

• store at room temperature

• protect from freezing

 • keep tightly closed

• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive Ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Active Ingredients (in Each 5 Ml Teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg

Structured Label Content

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)
Purposes

Antacid

Antigas

Warnings

Ask a doctor before use if you have

• kidney disease

• a magnesium-restricted diet

taking a prescription drug. Ask a doctor or pharmacist before use if you are

Antacids may interact with certain prescription drugs.

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

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

Directions

• shake well before use

• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• children under 12 years: ask a doctor

Other Information (Other information)

• magnesium 85 mg, sodium 1 mg each 5 mL teaspoonful contains:

• store at room temperature

• protect from freezing

 • keep tightly closed

• TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

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

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:50.426024 · Updated: 2026-03-14T22:53:51.342349