MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR- simethicone tablet, chewable

Mylanta Gas Minis Assorted Fruit Flavor by

Drug Labeling and Warnings

Mylanta Gas Minis Assorted Fruit Flavor by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 3 tablet dose)

Simethicone 125 mg

Purpose

Anti-gas

Uses

Relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of the reach of children.

Directions

• Adults and children 12 years and older : thoroughly chew 3-6 mini-tablets as needed.
  
  do not exceed 12 mini-tablets in 24 hours except under the advice and supervision of a physician.

Other information

• each dose contains: calcium 75 mg
  protect from heat and moisture
  store at 20-25° C (68-77° F)

Inactive ingredients

adipic acid , carboxymethylcellulose sodium ,D&C red 27 lake, FD&C blue 1 lake, FD &C yellow 6 lake, flavors, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, silica, sucralose, sucrose, tricalcium phosphate,

Questions or comments?

call 1-844-695-6624 toll free (English & Spanish)

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CONVENIENT POCKET PACK

Mylanta®

GAS Minis

• Fast relief of the bloating , pressure, and discomfort of gas
• Extra Strength, with the #1 selling medicine for gas relief
• Great tasting ,chewable mini-tablets in an on-the-go pack
• Also available in great tasting Arctic Mint & Cherry

TAMPER EVIDENT: DO NOT USE MYLANTA GAS MINI-TABLETS IF THE BREAKAWAY BAND ON TOP OF CONTAINER IS BROKEN OR MISSING.

•  
  Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Patent pending

infirst+

HEALTHCARE

Manufactured for:

Infirst Healthcare Inc.

Westport, CT 06880

©2016 Infirst Healthcare Inc.

Mylanta.com

KEEP OUTER PACKAGING FOR COMPLETE LABELING

Package level for 60 chewable tablets

Mylanta Pouch Pack Label

INGREDIENTS AND APPEARANCE

MYLANTA GAS MINIS ASSORTED FRUIT FLAVOR 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
ISOMALT (UNII: S870P55O2W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	PINK (LIGHT) , ORANGE, PURPLE	Score	no score
Shape	OVAL (OBLONG)	Size	12mm
Flavor	FRUIT (ASSORTED)	Imprint Code	MYLG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-801-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2016
2	NDC: 62372-801-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2016
3	NDC: 62372-801-03	3 in 1 POUCH; Type 0: Not a Combination Product	10/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	03/21/2016

Labeler - Infirst Healthcare Inc. (079159739)