PEDIACARE GAS RELIEF DROPS DYE FREE- simethicone emulsion and simethicone liquid

PediaCare Gas Relief Drops Dye Free by

Drug Labeling and Warnings

PediaCare Gas Relief Drops Dye Free by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone Emulsion USP 66.7mg/Simethicone 20 mg

Purpose

Anti-Gas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings

When using this product

do not exceed 12 doses per day

Keep out of reach of children.

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

Directions

• shake well before using
  
• all dosages may be repeated as needed, after meals and at bedtime
  
• fill enclosed dropper to recommended dosage level

Dose by weight or if weight information is not available, dose by age.

• dispense liquid slowly into baby’s mouth, toward inner cheek
  
• may mix with 1 oz. of cool water, infant formula or other suitable liquids
  
• clean dropper after each use and replace original cap

age (yr)	weight (lb)	dose
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 20-25ºC (68-77ºF)
  
• See bottle or box for lot number and expiration date

Inactive ingredients

citric acid, flavor, microcrystalline cellulose, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sucralose, xanthan gum

Questions or comments?

call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com

PRINCIPAL DISPLAY PANEL

INFANTS 0-36 months
PediaCare® we care for kidsTM
Gas Relief DROPS
SIMETHICONE-ANTI GAS
NON-STAINING
1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

PEDIACARE GAS RELIEF DROPS DYE FREE 
simethicone emulsion and simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-811
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	0.011 g  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.211 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-811-01	1 in 1 BOX
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	08/01/2011

Labeler - Medtech Products Inc. (122715688)