SPL v5
SPL
SPL Set ID 5b1f4c78-d42e-32c7-e053-2991aa0a1985
Route
ORAL
Published
Effective Date 2017-10-09
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 Sorbitol D&c Yellow No. 10 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-01

Description

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

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid Antigas

Description

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

Uses

relieves

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

Keep out of reach of children.

Purposes

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
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

• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor

• children under 12 years: ask a doctor

Package Label

Other Information

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 1 mg

• store at room temperature

• protect from freezing

 • keep tightly closed

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

Inactive Ingredients

benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10,  flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

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

Uses

relieves

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

Keep out of reach of children.

Purposes

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
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

• do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

• adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day, or as directed by a doctor

• children under 12 years: ask a doctor

Package Label (package Label)

Other Information (Other information)

each 5 mL teaspoonful contains: magnesium 165 mg, sodium 1 mg

• store at room temperature

• protect from freezing

 • keep tightly closed

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

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10,  flavor, glycerin, 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 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)