Label: SIGNATURE CARE INFANTS GAS RELIEF- simethicone emulsion
- NDC Code(s): 21130-015-10
- Packager: Safeway
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 26, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
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Directions
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- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
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- remove cap and insert syringe into the bottle
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- 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).
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- all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician
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- do not exceed 12 doses per day
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- dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
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- replace cap tightly to maintain child resistance
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- 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
- Questions or comments?
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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 emulsionProduct 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)
