LEADER ANTACIDREGULAR STRENGTH REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid
REMEDYREPACK INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cardinal Health Antacid Liquid Drug Facts

OTC - ACTIVE INGREDIENT

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

Magnesium hydroxide 200 mg

Simethicone 20 mg

OTC - PURPOSE

Antacid

Antigas

INDICATIONS & USAGE

relieves

heartburn
acid indigestion
sour stomach
upset stomach due to these symptoms
pressure and bloating commonly referred to as gas

WARNINGS

kidney disease
a magnesium-restricted diet

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

do not exceed 24 teaspoonsful (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

DOSAGE & ADMINISTRATION

shake well before use
adults and children 12 years and older: take 2-4 teaspoonsful (10-20 mL) between meals, at bedtime, or as directed by a doctor
children under 12: ask a doctor

STORAGE AND HANDLING

each teaspoon contains: calcium 25 mg and magnesium 85 mg
does not meet USP requirements for preservative effectiveness
store at 20°-25°C

INACTIVE INGREDIENT

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

OTC - QUESTIONS

1-800-719-9260

OTC - KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Leader AntacidRegular Strength Regular Strength

GENERIC: Aluminum hydroxide, Magnesium hydroxide, Simethicone

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 61786-193-07

ACTIVE INGREDIENT(S):

ALUMINUM HYDROXIDE 200mg in 5mL
DIMETHICONE 20mg in 5mL
MAGNESIUM HYDROXIDE 200mg in 5mL

INACTIVE INGREDIENT(S):

CELLULOSE, MICROCRYSTALLINE
PROPYLPARABEN
HYPROMELLOSES
WATER
BUTYLPARABEN
CARBOXYMETHYLCELLULOSE SODIUM
SILICON DIOXIDE
SORBITOL

COLOR: white

FLAVOR: MINT

PACKAGING: 355 mL in 1 BOTTLE

MM1

MM2

LEADER ANTACIDREGULAR STRENGTH REGULAR STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-193(NDC:37205-530)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-193-07	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2015	03/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/20/2015	03/13/2017

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017

Document Id: 4aa58e72-d0ec-09fb-e054-00144ff8d46c

Set id: be73dfdc-c329-470f-b8ac-0d9e99619696

Version: 2

Effective Time: 20170313

REMEDYREPACK INC.