Purpose
Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg . . . . . . . . . . . . . . . ……..Antigas
Little Remedies Infant Essentials
FDA Label NDC 63029-609
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Remedies Infant Essentials (NDC 63029-609). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding purpose, uses, directions, other information, inactive ingredients, other ingredients, keep out of reach of children., do not use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food
–Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.
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 years | under 24 | 0.3 mL |
| Children 2 years and over | 24 and over | 0.6 mL |
Other Information
■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)
■ See bottle or box for lot number and expiration date
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 12 | |
| Amount 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.
Keep Out Of Reach Of Children.
In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.
▪ 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.
Do Not Use If
- child has a history of kidney failure or renal problems
- child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant.
- Store at room temperature.
SALINE SPRAY + DROPS
Ingredients:
water, sodium chloride, glycerin, sodium benzoate, benzoic acid
Principal Display Panel
Little Remedies®
Infant Essentials Kit
GAS DROPS
SIMETHICONE /ANTIGAS
1 FL OZ (30 mL)
Syringe Included
SALINE SPRAY + DROPS
0.5 FL OZ (15 mL)
GRIPE WATER
GINGER / FENNEL SUPPLEMENT
2 FL OZ (59 mL)
Syringe Included
Principal Display Panellittle Remedies®infant Essentials Kitgas Dropssimethicone /antigas1 Fl Oz (30 mL)syringe Includedsaline Spray + Drops 0.5 Fl Oz (15 mL)gripe Water Ginger / Fennel Supplement2 Fl Oz (59 mL)syringe Included (Little Remedies Infant Essentials Kit 01)
* Please review the disclaimer below.
