SIGNATURE CARE INFANTS GAS RELIEF- simethicone emulsion

signature care infants gas relief by

Drug Labeling and Warnings

signature care infants gas relief by is a Otc medication manufactured, distributed, or labeled by Safeway. 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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 (towards 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

• do not use if printed bottle wrap is broken or missing
• store at 20-25°C (68-77°F)
• do not freeze

Inactive ingredients

anhydrous citric acid, flavor, hypromellose, maltitol solution, purified water, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

1-888-723-3929

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Compare to Infants’ Mylicon® Drops Non-Staining active ingredient

Quality Guaranteed

PEDIATRICIAN RECOMMENDED

#1 ACTIVE INGREDIENT

Infants’ Gas Relief Drops

SIMETHICONE 20 mg

Anti-Gas

Gently breaks down baby’s gas bubbles

Safe enough to use at every feeding**

**use as directed

DYE FREE

Non-staining

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SIGNATURE CARE INFANTS GAS RELIEF 
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-015
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYPROMELLOSES (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (white to off white, opaque)	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-015-10	1 in 1 CARTON	09/04/2015
1		30 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	09/04/2015

Labeler - Safeway (009137209)