MYLANTA GAS  MAXIMUM STRENGTH- dimethicone tablet, chewable 
McNeil Consumer Pharmaceuticals Co.

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.

----------

Mylanta®
Gas

Drug Facts

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Use

Warnings

Keep out of reach of children.

Directions

Other information

Inactive ingredients

D&C red no. 7 calcium lake, dextrates, flavors, magnesium stearate, modified starch, silicon dioxide, tribasic calcium phosphate

Questions or comments?

call 1-800-469-5268 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 16837-861-24

Mylanta®
Gas

SIMETHICONE • ANTI-GAS

MAXIMUM
STRENGTH

Fast Acting

CHERRY
Chewable Tablets

24 TABLETS-125 mg each

Principal Display Panel
MYLANTA GAS   MAXIMUM STRENGTH
dimethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:16837-861
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 125 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 16mm
Flavor CHERRY Imprint Code MYL;GAS;125
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16837-861-24 4 in 1 CARTON
1 6 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 06/01/1996
Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)

Revised: 3/2013
Document Id: 9a056551-8b8e-4a56-a702-bd5cf8ceb636
Set id: 7ef0be53-da4c-460c-90e6-2fc9e4552bf7
Version: 1
Effective Time: 20130319
 
McNeil Consumer Pharmaceuticals Co.