MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension 
MAJOR Pharmaceuticals 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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MAJ MI-ACID REG

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


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 12 years: ask a doctor

Other information

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

• 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

package Label

NDC 0904-0004-14

MAJOR

FAST ACTING

MI-ACID

Alumina, Magnesia and Simethicone Oral Suspension USP

Regular Strength

antacid/antigas

ORIGINAL

For fast, soothing Relief of:

HEARTBURN

ACID INDIGESTION

and SOUR STOMACH

compare to the active ingredients of Regular Strength MYLANTA

12 FL OZ (355 mL)

Alcohol: less than 0.5%

mi-acid reg label

MI-ACID REGULAR STRENGTH 
aluminum hydroxide, magnesium hydroxide, dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorLEMON (lemon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-0004-14355 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/01/201105/01/2022
Labeler - MAJOR Pharmaceuticals Inc. (191427277)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(0904-0004)

Revised: 12/2021
 
MAJOR Pharmaceuticals Inc.