MI-ACID MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

MI-ACID MAXIMUM STRENGTH by

Drug Labeling and Warnings

MI-ACID MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

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. In case of overdose, get medical help or contact a poison control center right away.

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 12 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

children under 12 years: ask a doctor

Other information

• each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg
• store at room temperature
• protect from freezing
• keep tightly closed

Inactive ingredients

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

Questions or comments?

Call 1-800-616-2471

package Label

NDC: 68788-9753-3

MAJOR

FAST ACTING

MI-ACID

Alumina, Magnesia and Simethicone Oral Suspension USP

Maximum Strength

antacid/antigas

ORIGINAL

For fast, soothing Relief of:

HEARTBURN

ACID INDIGESTION

and SOUR STOMACH

compare to the active ingredients of Maximum Strength MYLANTA

12 FL OZ (355 mL)

Alcohol: 0.5%

Relabeled By: Preferred Pharmaceuticals Inc.

INGREDIENTS AND APPEARANCE

MI-ACID MAXIMUM STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-9753(NDC:0904-0005)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	400 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	400 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	40 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-9753-3	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/14/2018

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-9753)