kro antacid mint

kro antacid mint
SPL v3
SPL
SPL Set ID b9e5fc3f-caf0-84c4-e053-2a95a90af655
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
hypromelloses cellulose, microcrystalline butylparaben propylparaben water saccharin sodium sorbitol solution carboxymethylcellulose sodium benzyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-03-01

Purpose

Antacid Antigas

Description

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


Medication Information

Warnings

Do not take more than 80 mL (8 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.

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 10 mL to 20 mL (1 to 2 doses) four times a day or as directed by a doctor.
  • children under under 12 years: ask a doctor
  • measure with dosing cup provided
  • mL=milliliter
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, carboxymethylcellulose sodium, flavor, 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 40 mg

Section 50565-1

Keep out of reach of children.

Purposes

Antacid

Antigas

Package Label

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

Warnings

Do not take more than 80 mL (8 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.

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • the symptoms referred to as gas

Directions
  • shake well before use
  • adults and children 12 years and older: take 10 mL to 20 mL (1 to 2 doses) four times a day or as directed by a doctor.
  • children under under 12 years: ask a doctor
  • measure with dosing cup provided
  • mL=milliliter
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, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Section 50565-1 (50565-1)

Keep out of reach of children.

Purposes

Antacid

Antigas

Package Label (package label)

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)