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

MAGSIL ANTACID (LEMON MINT) by

Drug Labeling and Warnings

MAGSIL ANTACID (LEMON MINT) by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Antacid
Antacid
Antiflatulent

INDICATIONS & USAGE

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

WARNINGS

Warnings
Do not use
more than 20 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 DOCTOR

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

ASK DOCTOR/PHARMACIST

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
adults and children 12 years of age or over: take two tablets, well chewed, 30 minutes after meals, at bedtime, or when symptoms occur, or as directed by a physician. Do not exceed 20 tablets in 24 hours.
children under 12 years of age: consult a doctor

OTHER SAFETY INFORMATION

Other information
each chewable tablet contains:  magnesium 85 mg
Phenylketonurics: Contains Phenylalanine 1.684 mg per chewable tablet
keep tightly sealed
store between 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

Magsil Antacid

Lemon Mint

Safely Sealed

NDC: 51467-100-01

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

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

Sugar Free

24 Chewable Tablets

In Individually Sealed Strip

Alimentary Series

INGREDIENTS AND APPEARANCE

MAGSIL ANTACID (LEMON MINT) 
aluminum hydroxide dried gel, magnesium hydroxide, and simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-100
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
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	21 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	ROUND	Size	16mm
Flavor	LEMON, MINT	Imprint Code	MAGSIL;FORTUNE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-100-01	4 in 1 BOX	09/22/2017
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	09/20/2017

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-100)