little remedies infant essentials kit

little remedies infant essentials kit
SPL v1
SPL
SPL Set ID be96e634-0dae-4c0b-87b2-a000da2543d3
Routes
oral nasal
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (20 mg) ginger (5 mg) fennel (4 mg)
Inactive Ingredients
carboxymethylcellulose sodium citric acid monohydrate cellulose, microcrystalline propylene glycol water sodium benzoate sucrose xanthan gum agave tequilana juice glycerin potassium sorbate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
unapproved drug other active Since 2019-02-15
Purpose

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg . . . . . . . . . . . . . . . ……..Antigas

Description

GAS RELIEF DROPS   Simethicone / Antigas Drug Facts

Medication Information

Uses

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

Purpose

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg . . . . . . . . . . . . . . . ……..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 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
Description

GAS RELIEF DROPS   Simethicone / Antigas Drug Facts

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

Ing

water, sodium chloride, glycerin, sodium benzoate, benzoic acid

Section 42229-5

GAS RELIEF DROPS   Simethicone / Antigas

Drug Facts

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  

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.

Structured Label Content

Uses

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

Purpose

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg . . . . . . . . . . . . . . . ……..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 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 (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,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
Principal Display Panel (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

Ing

water, sodium chloride, glycerin, sodium benzoate, benzoic acid

Section 42229-5 (42229-5)

GAS RELIEF DROPS   Simethicone / Antigas

Drug Facts

Do Not Use If (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  

Other Ingredients (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. (Keep out of reach of children.)

In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:00.392649 · Updated: 2026-03-14T22:55:50.118517