Label: LITTLE REMEDIES INFANT ESSENTIALS (simethicone emulsion, simethicone, zingiber officinale (ginger) root, foeniculum vulgare- fennel seed kit
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Contains inactivated NDC Code(s)
NDC Code(s): 63029-609-01 - Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 1, 2020
If you are a consumer or patient please visit this version.
- 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 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 oz. of cool water, infant formula or other suitable liquids
■ for best results, clean syringe after each use and replace original cap
If possible, use weight to determine dose; otherwise use age.
mL = milliliters
Age (yrs) Weight (lbs) Dose Newborns &
Infants under 2 yearsunder 24 0.3 mL Children 2 years and over 24 and over 0.6 mL - Other information
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Inactive ingredients
carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum
GRIPE WATER
Supplement Facts
Serving Size: 5 mL
Servings per Container: about 12Amount per Serving % Daily Value Zingiber officinale (Ginger) Root Extract 5 mg † Foeniculum vulgare (Fennel) Seed Extract 4mg † †Daily Value not established -
Other ingredients
purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum
Suggested Use Age Dose 2 to 4 weeks 2.5 mL 1 to 6 months 5 mL 6 months and older 10 mL Adults 30 mL SHAKE WELL. May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing.
- Uses
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Warnings
Keep out of reach of children.
▪ The use of this dispenser by more than one person may spread infection.
▪ Wipe nozzle clean after each use.
Directions (For nasal use only)
▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor.
▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.
Store at 20°-25°C (68°-77°F).
See bottle for lot and expiration date.
- Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LITTLE REMEDIES INFANT ESSENTIALS
simethicone emulsion, simethicone, zingiber officinale (ginger) root, foeniculum vulgare (fennel) seed kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-609 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-609-01 1 in 1 CARTON; Type 0: Not a Combination Product 02/15/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 mL Part 2 1 BOTTLE, DROPPER 15 g Part 3 1 BOTTLE 59 mL Part 1 of 3 LITTLE REMEDIES RELIEF
simethicone liquidProduct Information 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 BOTTLE; 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 02/15/2017 Part 2 of 3 SALINE
other baby products sprayProduct Information Route of Administration NASAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR WATER (UNII: 059QF0KO0R) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) Product Characteristics Color WHITE (Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 g 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 COSMETIC 02/15/2017 Part 3 of 3 GRIPE WATER
ginger root / fennel seed liquidProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 5 mg in 5 mL FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL 4 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 02/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/15/2019 Labeler - Medtech Products Inc. (122715688)
