MAGSIL ANTACID (LEMON MINT)- aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewable 
FORTUNE PHARMACAL COMPANY LIMITED

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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DRUG FACTS

Active ingredients (in each tablet)
Aluminum hydroxide dried gel 200 mg
Magnesium hydroxide 200 mg
Simethicone 21 mg

Purpose
Antacid
Antacid
Antiflatulent

Uses
■ for the relief of pressure and bloating commonly referred to as gas, associated with the following:
   ■ heartburn
   ■ sour stomach
   ■ acid indigestion

Warnings
Do not use
■ more than 12 tablets in a 24-hour period
■ the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

Ask a doctor before use if you have
■ kidney disease
■ a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

Keep this and all drugs out of the reach of children.

Directions
■ adults and children 12 years of age or older: take two tablets, well chewed, 30 minutes after meals, at bedtime, or when symptoms occur, or as directed by a physician. Do not exceed 12 tablets in 24 hours.
■ children under 12 years of age: consult a doctor

Other information
■ each chewable tablet contains: 85 mg of magnesium
■ Phenylketonurics: Contains Phenylalanine 1.684 mg Per Chewable Tablet
■ keep tightly sealed
■ store below 25 C (77 F) in a dry place, away from direct sunlight

Inactive ingredients
aspartame, corn starch, D&C yellow no. 10 aluminum lake, lemon flavor, magnesium stearate, mannitol, peppermint flavor, povidone K30

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

MAGSIL Antacid

Lemon Mint

Safely Sealed

NDC 51467-100-01

Aluminum Hydroxide Dried Gel - Antacid
Magnesium Hydroxide - Antacid
Simethicone - Antiflatulent

Recommended for
■ Gas
■ Sour Stomach
■ Heartburn
■ Acid Indigestion

24 Tablets

In Individually Sealed Strip

Sugar Free
IMAGE OF 24 TABLETS BOX

MAGSIL ANTACID (LEMON MINT) 
aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE21 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize16mm
FlavorLEMON, MINTImprint Code MAGSIL;FORTUNE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51467-100-014 in 1 BOX09/22/2017
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33109/20/2017
Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-100)

Revised: 2/2021
Document Id: 2a111c73-7bca-4f5c-9caf-196d2db754b2
Set id: 8a1783d3-421b-481f-8517-db82cb837b24
Version: 5
Effective Time: 20210222
 
FORTUNE PHARMACAL COMPANY LIMITED