Label: SIMETHICONE solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-5620-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0603-0894
- 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 2, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
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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 and dispense 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
- for best results, clean dropper after each use and replace original cap
Age Weight Dose newborn - - - - 0.3 mL infants under 2 years under 24 lbs 0.3 mL children over 2 years over 24 lbs 0.6 mL - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5620(NDC:0603-0894) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 63.3 mg in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 3.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) HYPROMELLOSES (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5620-0 1 in 1 CARTON 1 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 10/30/2007 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel
