LITTLE REMEDIES GAS RELIEF DROPS- simthicone liquid

Little Remedies by

Drug Labeling and Warnings

Little Remedies by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, 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 66.7 mg/ Simethicone 20 mg

Purpose

Antigas

Uses

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

Warnings

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 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

Questions?

1-800-754-8853

Mon. – Fri. 8:30 am to 5:30 pm EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES  GAS RELIEF DROPS
simthicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1237
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1237-02	1 in 1 CARTON	01/01/2017
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0295-1237-05	1 in 1 CARTON	01/01/2017
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE(0295-1237)