Label: INFANTS- simethicone suspension/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 17856-1303-1, 17856-1303-2, 17856-1303-3, 17856-1303-4, view more17856-1303-5 - Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0536-1303
- 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 June 30, 2021
If you are a consumer or patient please visit this version.
- 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, 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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
INFANTS
simethicone suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-1303(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 FORM (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 PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-1303-1 120 in 1 BOX, UNIT-DOSE 06/30/2021 1 0.3 mL in 1 SYRINGE; Type 0: Not a Combination Product 2 NDC:17856-1303-2 120 in 1 BOX, UNIT-DOSE 06/30/2021 2 0.3 mL in 1 SYRINGE; Type 0: Not a Combination Product 3 NDC:17856-1303-3 120 in 1 BOX, UNIT-DOSE 06/30/2021 3 0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product 4 NDC:17856-1303-4 120 in 1 BOX, UNIT-DOSE 06/30/2021 4 0.6 mL in 1 SYRINGE; Type 0: Not a Combination Product 5 NDC:17856-1303-5 60 in 1 BOX, UNIT-DOSE 06/30/2021 5 1.2 mL in 1 SYRINGE; 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 09/01/2020 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-1303) , repack(17856-1303)
