MYLICON INFANTS GAS RELIEF ORIGINAL- simethicone emulsion
Mylicon Infants Gas Relief Original by
Drug Labeling and Warnings
Mylicon Infants Gas Relief Original by is a Otc medication manufactured, distributed, or labeled by Infirst Healthcare. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
-
Directions
- shake well before using
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- remove cap and insert syringe into the bottle
- pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
- do not exceed 12 doses per day.
- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
- replace cap tightly to maintain child resistance
- mL = milliliter
Age (yr)
Weight (lb)
Dose (mL)
infants under 2
under 24
0.3
children over 2
over 24
0.6
- Other information
- Inactive ingredients
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Principal Display Panel
Infants' Mylicon®
Simethicone-Antigas
Gas Relief
Gently breaks down baby’s gas bubbles
Original Drops
Non-staining
Safe enough to use at every feeding and up to 12 times per day*
#1 Brand
Recommended by Pediatricians
1 Fl. OZ (30ml)
100 Doses
Visit us at mylicon.com
No Alcohol
No Artificial Flavors
No Saccharin
Gluten Free
Safe enough to use at every feeding and up to 12 times per day*
Safe enough for even the newest of newborns*
*use as directed
Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.
Important: Keep this carton for future reference on full labeling
Manufactured for
infirst Healthcare Inc.
Westport, CT 06880
©2015 infirst Healthcare Inc.
Package Label for 30 mL
Package Label for 15 mL
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INGREDIENTS AND APPEARANCE
MYLICON INFANTS GAS RELIEF ORIGINAL
simethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 62372-630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color PINK (pink) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 62372-630-30 1 in 1 CARTON 03/31/2015 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC: 62372-630-15 1 in 1 CARTON 03/31/2015 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 03/31/2015 Labeler - Infirst Healthcare (079159739)
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