Label: INFANTS RELIEF NON-STAINING FORMULA- dimethicone 410 liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-102-05 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
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 14, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 0.3 mL)
- Purpose
- Uses
- Warnings
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Directions
- shake well before using
- all doses 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 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 (yr) Weight (lb) Dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL - Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
INFANTS RELIEF NON-STAINING FORMULA
dimethicone 410 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone 410 (UNII: TYU5GP6XGE) (Dimethicone 410 - UNII:TYU5GP6XGE) Dimethicone 410 20 mg in 0.3 mL Inactive Ingredients Ingredient Name Strength Sodium Benzoate (UNII: OJ245FE5EU) Citric Acid Monohydrate (UNII: 2968PHW8QP) Hypromelloses (UNII: 3NXW29V3WO) Sucralose (UNII: 96K6UQ3ZD4) Vanillin (UNII: CHI530446X) Sodium Citrate (UNII: 1Q73Q2JULR) Water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor VANILLA, STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-102-05 1 in 1 CARTON 1 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 02/03/2012 Labeler - CVS (062312574) Registrant - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE, PACK, LABEL, ANALYSIS