SPL v2
SPL
SPL Set ID b95edae9-58b8-4c5f-82f4-28a4599f1907
Route
ORAL
Published
Effective Date 2012-07-17
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 2011-01-05

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

• kidney disease • a magnesium-restricted diet taking a prescription drug. Antacids may interact with certain prescription drugs. symptoms last more than 2 weeks Ask a doctor before use if you have





Ask a doctor or pharmacist before use if you are







Stop use and ask a doctor if

Directions

• shake well before use • adults and children 12 years and older: take 2 to 4 teaspoonfuls four times a day, or as directed by a doctor • do not take more than 16 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 • store at room temperature each 5 mL teaspoonful contains:

• 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, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions Or Comments?

Call 1-800-645-2158, 9am -5 pm ET, Monday-Friday

Active Ingredients (in Each 5 Ml Teaspoonful)

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



Rulox Regular (aluminum Hydroxide, Magnesium Hydroxide, Dimethicone) Suspension

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

• kidney disease • a magnesium-restricted diet taking a prescription drug. Antacids may interact with certain prescription drugs. symptoms last more than 2 weeks Ask a doctor before use if you have





Ask a doctor or pharmacist before use if you are







Stop use and ask a doctor if

Directions

• shake well before use • adults and children 12 years and older: take 2 to 4 teaspoonfuls four times a day, or as directed by a doctor • do not take more than 16 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 • store at room temperature each 5 mL teaspoonful contains:

• 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, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions Or Comments? (Questions or comments?)

Call 1-800-645-2158, 9am -5 pm ET, Monday-Friday

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



Rulox Regular (aluminum Hydroxide, Magnesium Hydroxide, Dimethicone) Suspension (RULOX REGULAR (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE) SUSPENSION)

Advanced Ingredient Data


Raw Label Data

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