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

MI-ACID REGULAR STRENGTH by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (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

taking a prescription drug. Ask a doctor or pharmacist before use if you are

Antacids may interact with certain prescription drugs.

symptoms last more than 2 weeks Stop use and ask a doctor if

ask a health professional before use. If pregnant or breast-feeding,

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 12 years: ask a doctor

Other information

magnesium 85 mg, sodium 1 mg each 5 mL teaspoonful contains:

store at room temperature

protect from freezing

  keep tightly closed

TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64725-0004(NDC:0904-0004)
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (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: 64725-0004-1	12 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	02/01/2011

Labeler - TYA Pharmaceuticals (938389038)

Registrant - TYA Pharmaceuticals (938389038)

Establishment
Name	Address	ID/FEI	Business Operations
TYA Pharmaceuticals		938389038	RELABEL(64725-0004) , REPACK(64725-0004)