Ldr Ant Mnt

Ldr Ant Mnt
SPL v3
SPL
SPL Set ID af5ea189-2118-4ffd-e053-2995a90aecfd
Route
ORAL
Published
Effective Date 2014-07-17
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 Saccharin Sorbitol Solution

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

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. In case of overdose, get medical help

or contact Poison Control Center (1-800-222-1222) right away.

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 each use

• adults and children 12 years and older: take 10 mL to 20 mL

(1-2 doses) four times a day or as directed by a doctor

• do not exceed 80 mL (8 doses) in a 24 hour period or use the

maximum dosage for more than 2 weeks

• children under 12 years: ask a doctor

Package Label

Other Information

• each 10 mL dose contains: magnesium 165 mg, sodium 6 mg

• store at room temperature

• protect from freezing

• keep tightly closed

Inactive Ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Questions Or Comments?

1-800-540-3765

Active Ingredients (in Each 10 Ml Dose)

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. In case of overdose, get medical help

or contact Poison Control Center (1-800-222-1222) right away.

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 each use

• adults and children 12 years and older: take 10 mL to 20 mL

(1-2 doses) four times a day or as directed by a doctor

• do not exceed 80 mL (8 doses) in a 24 hour period 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 10 mL dose contains: magnesium 165 mg, sodium 6 mg

• store at room temperature

• protect from freezing

• keep tightly closed

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?)

1-800-540-3765

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 40mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)