SUNMARK INFANTS GAS RELIEF DROPS- simethicone emulsion

Sunmark infants gas relief drops by

Drug Labeling and Warnings

Sunmark infants gas relief drops by is a Otc medication manufactured, distributed, or labeled by McKesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of the reach of children.

Directions

• shake well before using
• all dosages may be repeated as needed, after meals and at bedtime
• fill enclosed dropper to recommended dosage level
• dispense liquid slowly into baby's mouth, toward the inner cheek
• may mix with 1 oz. of cool water, infant formula or other suitable liquids
• clean dropper after each use replace original cap.

  age (yr)	weight (lb)	dose
  infants under 2	under 24	0.3 mL
  children over 2	over 24	0.6 mL

Other information

store at room temperature (59oF-86oF)

Inactive ingredients

benzoic acid, red # 22, red # 28, flavor, magnesium aluminum silicate, purified water, sorbitol, xanthan gum.

Principal Display Panel

Sunmark

compare to Mylicon® Infant drops active ingredient

gas relief drops infants'

Fast relief of gas symptoms

Alcohol and Saccharin free

No artificial flavor

1 fl oz (30 mL) 100 Doses

INGREDIENTS AND APPEARANCE

SUNMARK INFANTS GAS RELIEF DROPS 
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-577
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-577-34	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/31/2003

Labeler - McKesson (177667227)