ADVANCED ANTACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone liquid

ADVANCED ANTACID REGULAR STRENGTH by

Drug Labeling and Warnings

ADVANCED ANTACID REGULAR STRENGTH by is a Otc medication manufactured, distributed, or labeled by STRATEGIC SOURCING SERVICES LLC, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

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

Purposes

Antacid

Antigas

Uses

relieves

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

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.

Keep out of reach of children.

Directions

• shake well before use
• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
• do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
• children under under 12 years: ask a doctor

Other information

• each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg
• protect from freezing
• store at room temperature
• keep tightly closed

Inactive ingredients

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

package label

Sunmark

compare to active ingredients of the Regular Strength Mylanta®*

NDC: 49348-153-39

advanced

antacid

Regular Strength

antacid/antigas

Alumina, Magnesia
and Simethicone
Oral Suspension

Fast acting
soothing relief of
heartburn,
acid indigestion,
sour stomach,
pressure & bloating

ORIGINAL FLAVOR

Alcohol 0.15%

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

ADVANCED ANTACID REGULAR STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-153
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-153-39	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/01/2012

Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(49348-153)