Qc Ant Org

Qc Ant Org
SPL v3
SPL
SPL Set ID 9f410b3a-5579-4fae-84b1-5cd35563451e
Route
ORAL
Published
Effective Date 2014-07-21
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 Hydroxyethyl Cellulose, Unspecified Propylparaben Water Saccharin Sorbitol Solution

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-01

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.

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

• 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

Package Label

Other Information

each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg

• store at room temperature

• protect from freezing

• keep tightly closed

Inactive Ingredients

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions Or Comments?

1-800-540-3765

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.

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

• 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

Package Label (package Label)

Other Information (Other information)

each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg

• store at room temperature

• protect from freezing

• keep tightly closed

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions Or Comments? (Questions or Comments?)

1-800-540-3765

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)