Label: MYLICON- simethicone suspension
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NDC Code(s):
17856-0799-1,
17856-0799-2,
17856-0799-3,
17856-0799-4, view more17856-0799-5
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 57896-798
- 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 May 16, 2023
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
- Use
- Warnings
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Directions
- shake well before using
- 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
- fill enclosed dropper to recommended dosage level anddispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
- clean dropper well after each use and replace original cap on bottle
Age (years) Weight (lbs) Dose infants (under 2) under 24 0.3 mL children (2 and over)
24 and over 0.6 mL - Other information
- Inactive ingredients
- Questions or comments?
- Package Label
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INGREDIENTS AND APPEARANCE
MYLICON
simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-0799(NDC:57896-798) 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MALTITOL (UNII: D65DG142WK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-0799-1 120 in 1 BOX, UNIT-DOSE 04/06/2023 1 0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:17856-0799-2 120 in 1 BOX, UNIT-DOSE 04/06/2023 2 0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:17856-0799-3 120 in 1 BOX, UNIT-DOSE 04/06/2023 3 0.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 4 NDC:17856-0799-4 120 in 1 BOX, UNIT-DOSE 04/06/2023 4 0.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 5 NDC:17856-0799-5 60 in 1 BOX, UNIT-DOSE 04/06/2023 5 1.2 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 05/01/2014 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations UNIT DOSE SOLUTIONS 360804194 repack(17856-0799)