LITTLE REMEDIES INFANT ESSENTIALS- simethicone emulsion, simethicone, zingiber officinale (ginger) root, foeniculum vulgare (fennel) seed 
Medtech Products Inc.

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.

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Little Remedies Infant Essentials Kit

GAS RELIEF DROPS Simethicone / Antigas

Drug Facts

Active ingredient (in each 0.3 mL)

Purpose

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

Uses

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

Warnings

Keep out of reach of children.

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 240.3 mL
Children 2 years 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,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
AgeDose
2 to 4 weeks2.5 mL
1 to 6 months5 mL
6 months and older10 mL
Adults30 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.

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 

Uses

–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.

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:

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 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

LITTLE REMEDIES INFANT ESSENTIALS 
simethicone emulsion, simethicone, zingiber officinale (ginger) root, foeniculum vulgare (fennel) seed kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-609
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-609-011 in 1 CARTON; Type 0: Not a Combination Product02/15/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 21 BOTTLE, DROPPER 15 g
Part 31 BOTTLE 59 mL
Part 1 of 3
LITTLE REMEDIES RELIEF 
simethicone liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33202/15/2017
Part 2 of 3
SALINE 
other baby products spray
Product Information
Route of AdministrationNASAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorWHITE (Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
115 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC02/15/2017
Part 3 of 3
GRIPE WATER 
ginger root / fennel seed liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER5 mg  in 5 mL
FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT02/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/15/2019
Labeler - Medtech Products Inc. (122715688)

Revised: 1/2020
Document Id: 4923de4c-6a94-4018-9215-a36a7c5c8c13
Set id: be96e634-0dae-4c0b-87b2-a000da2543d3
Version: 1
Effective Time: 20200101
 
Medtech Products Inc.