SPL v1
SPL
SPL Set ID e2a14762-3860-44c3-a3ea-5dbc45f4b1d5
Route
ORAL
Published
Effective Date 2012-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (200 mg) Magnesium Hydroxide (20 mg) Dimethicone
Inactive Ingredients
Silicon Dioxide Butylparaben Carboxymethylcellulose Sodium Hypromelloses Cellulose, Microcrystalline Propylparaben Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-12-12

Description

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

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid

Antigas

Description

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

Uses

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas
Directions
  • shake well before using
  • adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
  • children under 12: ask a doctor
Other Information
  • each teaspoon contains: calcium 25 mg and magnesium 85 mg
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for preservative effectiveness
Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Questions Or Comments?

1-800-719-9260

Principal Display Panel
Regular Strength



Liquid Antacid



Antacid & Anti-Gas



Fast Relief of:



Heartburn



Acid Indigestion



Sour Stomach & Upset Stomach



Mint Flavor



Maalox Antacid     12 fl oz (355 mL)



NDC 54868-2093-0





When Using This Product

do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Ask A Doctor Before Use If You Have
  • kidney disease
  • a magnesium-restricted diet
Active Ingredient (in Each 5 Ml Teaspoon)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Ask A Doctor Or Pharmacist Before Use If You Are

now taking a prescription drug. Antacids may interact with certain prescription drugs.


Structured Label Content

Uses

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas
Purpose

Antacid

Antigas

Directions
  • shake well before using
  • adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
  • children under 12: ask a doctor
Other Information (Other information)
  • each teaspoon contains: calcium 25 mg and magnesium 85 mg
  • store at 20°-25°C (68°-77°F)
  • does not meet USP requirements for preservative effectiveness
Inactive Ingredients (Inactive ingredients)

butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel
Regular Strength



Liquid Antacid



Antacid & Anti-Gas



Fast Relief of:



Heartburn



Acid Indigestion



Sour Stomach & Upset Stomach



Mint Flavor



Maalox Antacid     12 fl oz (355 mL)



NDC 54868-2093-0





When Using This Product (When using this product)

do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium-restricted diet
Active Ingredient (in Each 5 Ml Teaspoon) (Active ingredient (in each 5 mL teaspoon))

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 20 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

now taking a prescription drug. Antacids may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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