fos max antacid

SPL v2

SPL

SPL Set ID fd00ead8-026c-6610-e053-6394a90a0f11

Route

oral

Published

Effective Date 2013-08-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

aluminum hydroxide (400 mg) hydroxide ion (40 mg) dimethicone

Inactive Ingredients

benzyl alcohol butylparaben carboxymethylcellulose sodium hypromelloses cellulose, microcrystalline propylparaben water saccharin sorbitol solution

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-05-01

Purpose

Antacid Antigas

Description

Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg

Medication Information

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet

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

Antacids may interact with certain prescription drugs.

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

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

Uses

relieves

heartburn
sour stomach
acid indigestion
the symptoms referred to as gas

Purpose

Antacid

Antigas

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 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years of age: ask a doctor

Other Information

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
store at room temperature
protect from freezing
keep tightly closed

Inactive Ingredients

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

Description

Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg

Section 50565-1

Keep out of reach of children.

Package Label

Questions Or Comments?

Call 833-358-6431

Active Ingredients (in Each 5 Ml Teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

Structured Label Content

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet

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

Antacids may interact with certain prescription drugs.

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

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

Uses

relieves

heartburn
sour stomach
acid indigestion
the symptoms referred to as gas

Purpose

Antacid

Antigas

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 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
children under 12 years of age: ask a doctor

Other Information (Other information)

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
store at room temperature
protect from freezing
keep tightly closed

Inactive Ingredients (Inactive ingredients)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Package Label (package Label)

Questions Or Comments? (Questions or comments?)

Call 833-358-6431

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

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves heartburn sour stomach acid indigestion the symptoms referred to as gas", "50565-1": "Keep out of reach of children.", "Purpose": "Antacid Antigas", "Warnings": "Ask a doctor before use if you have kidney disease a magnesium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use.", "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 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks children under 12 years of age: ask a doctor", "Other information": "each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg store at room temperature protect from freezing keep tightly closed", "Inactive ingredients": "benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution", "Questions or comments?": "Call 833-358-6431", "Active ingredients (in each 5 mL teaspoonful)": "Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.190182 · Updated: 2026-03-14T23:01:45.300207