LEADER ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0), MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antacid Antigas for the relief of
Authorization status:
OTC monograph final
Authorization number:
70000-0486-1

LEADER ANTACID- aluminum hydroxide, magnesium hydroxide, simethicone suspension

Cardinal Health

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

Active ingredients (in each 10 mL)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpos e

Antacid

Antigas

Us es

for the relief of

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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

When using this product

do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks,

except under the advice and supervision of a physician

Keep out of reach of children.

Directions

acid indigestion

heartburn

sour stomach

upset stomach associated with these symptoms

pressure and bloating commonly referred to as gas

kidney disease

a magnesium-restricted diet

shake well before using

Other information

Inactive ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium,

peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol,

sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Regular Strength

Antacid Liquid

Aluminum Hydroxide | Magnesium Hydroxide

Simethicone | Antacid | Antigas

Mint Flavor

Fast Relief of:

Heartburn

Acid Indigestion

Pressure & Bloating

100% Money Back Guarantee

12 FL OZ (355 mL)

only use the dose cup provided

adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a

physician

do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks

children under 12 years: consult a physician

each 10 mL contains: magnesium 175 mg

does not meet USP requirements for preservative effectiveness

store at 20-25ºC (68-77ºF)

protect from freezing

LEADER ANTACID

aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 48 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 ) (ALUMINUM HYDROXIDE - UNII:5QB0 T2IUN0 )

ALUMINUM

HYDROXIDE

40 0 mg

in 10 mL

MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S) (MAGNESIUM CATION - UNII:T6 V3LHY8 38 ,

HYDROXIDE ION - UNII:9 159 UV38 1P)

MAGNESIUM

HYDROXIDE

40 0 mg

in 10 mL

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

40 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Cardinal Health

SO RBITO L (UNII: 50 6 T6 0 A25R)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

WHITE (o paque)

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 0 0 -0 48 6 -1 355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/23/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt332

0 4/23/20 19

Labeler -

Cardinal Health (097537435)

Revised: 4/2019

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