Little Remedies Liquid
FDA Label NDC 63029-103

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 (NDC 63029-103). 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 active ingredient (in each 0.3 ml), purpose, uses, keep out of reach of children., directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 0.3 Ml)

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

Purpose

Antigas

Uses

Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 2Under 240.3 mL
    Children 2 and over24 and over0.6 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 (and) microcrystalline cellulose, citric acid, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Questions?

1-800-754-8853

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com

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Little Remedies
Gas Relief Drops
Simethicone / Antigas
0.5 FL OZ (15 mL)

Little Remedies Gas Relief Drops 0.5 Fl Oz (15 mL) Carton (Little Remedies Gas Relief Drops 01)

Little Remedies Gas Relief Drops 0.5 Fl Oz (15 mL) Carton (Little Remedies Gas Relief Drops 01)

Little Remedies
Gas Relief Drops
Simethicone / Antigas
1.0 FL OZ (30 mL)

Little Remedies Gas Relief Drops 1.0 Oz Carton (Little Remedies Gas Relief Drops 02)

Little Remedies Gas Relief Drops 1.0 Oz Carton (Little Remedies Gas Relief Drops 02)

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