Label: INFANTS- simethicone suspension/ drops
- NDC Code(s): 0536-1303-75
- Packager: RUGBY LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 11, 2023
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- 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, simply push syringe back until you have reached the described 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
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Principal Display Panel
Rugby®
Compare to the active ingredient in Infants’ Mylicon® Drops*
NDC 0536-1303-75
Infants’
Simethicone Drops
Antigas
- •
- Dye-free
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- Non-staining formula
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- No Saccharin
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- No Artificial Color
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- No Artificial Flavor
1 FL OZ (30 mL) 100 DOSES
Distributed by:
RUGBY LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Syringe Enclosed. This bottle contains 100 doses (0.3 mL/dose)
*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ MYLICON® Drops.
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INGREDIENTS AND APPEARANCE
INFANTS
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1303 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 (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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 WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1303-75 1 in 1 CARTON 09/01/2020 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 Drug M002 09/01/2020 Labeler - RUGBY LABORATORIES (079246066)
