Label: LITTLE REMEDIES GAS RELIEF DROPS- simthicone liquid
- NDC Code(s): 63029-103-01, 63029-103-02
- Packager: Medtech Products Inc.
- 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 December 12, 2017
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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
- only use enclosed dropper / syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek
- 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
- dosage can also be mixed with 1 fl oz of cool water, infant formula or other suitable liquids
- for best results, clean dropper after each use and replace original cap
If possible, use weight to determine dose; otherwise use age.
mL = milliliter
Age (yrs) Weight (lbs) Dose Newborns & Infants under 2 Under 24 0.3 mL Children 2 and over 24 and over 0.6 mL - Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LITTLE REMEDIES GAS RELIEF DROPS
simthicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-103 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 (UNII: K679OBS311) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-103-01 1 in 1 CARTON 06/01/2012 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:63029-103-02 1 in 1 CARTON 01/04/2010 2 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 FINAL part332 01/04/2010 Labeler - Medtech Products Inc. (122715688)
