Kro Antacid Org

Kro Antacid Org
SPL v3
SPL
SPL Set ID b9e61a03-e008-50ab-e053-2a95a90a3210
Route
ORAL
Published
Effective Date 2016-06-15
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
Butylparaben Propylparaben Water Saccharin Sodium Sorbitol Solution Hydroxyethyl Cellulose, Unspecified Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

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

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid Antigas

Description

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

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

Do not take more than 120 mL (12 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks .

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.

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

Directions
  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor.
  • children under under 12 years: ask a doctor
  • measure with dosing cup provided
  • mL=milliliter
Package Label

Other Information
  • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
  • protect from freezing
  • store at room temperature
  • keep tightly closed
Inactive Ingredients

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

Questions Or Comments?

1-800-632-6900

Active Ingredients (in Each 10 Ml Dose)

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

Magnesium hydroxide 400 mg

Simethicone 40 mg


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

Do not take more than 120 mL (12 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks .

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.

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

Directions
  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime, or as directed by a doctor.
  • children under under 12 years: ask a doctor
  • measure with dosing cup provided
  • mL=milliliter
Package Label (package label)

Other Information (Other information)
  • each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
  • protect from freezing
  • store at room temperature
  • 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?)

1-800-632-6900

Active Ingredients (in Each 10 Ml Dose) (Active ingredients (in each 10 mL dose))

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

Magnesium hydroxide 400 mg

Simethicone 40 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)