Little Remedies Gas Relief Drops

Little Remedies Gas Relief Drops
SPL v6
SPL
SPL Set ID 874d3f1d-1e4a-49ab-8285-4d6bf2601d5e
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Microcrystalline Cellulose Citric Acid Monohydrate Propylene Glycol Water Sodium Benzoate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2010-01-04 Until 2023-07-31

Description

Drug Facts

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

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 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
  • 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

Principal Display Panel

Little Remedies

Gas Relief Drops

Simethacone / Antigas

0.5 FL OZ (15 mL)

Questions? 1 800 754 8853

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com

Active Ingredient (in Each 0.3 Ml)

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antigas

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 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 (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 (Inactive ingredients)

carmellose sodium (and) microcrystalline cellulose, citric acid, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Little Remedies

Gas Relief Drops

Simethacone / Antigas

0.5 FL OZ (15 mL)

Questions? 1 800 754 8853 (Questions? 1-800-754-8853)

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com

Active Ingredient (in Each 0.3 Ml) (Active ingredient (in each 0.3 mL))

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)