INFANTS GAS RELIEF DROPS- simethicone suspension/ drops

INFANTS GAS RELIEF DROPS by

Drug Labeling and Warnings

INFANTS GAS RELIEF DROPS by is a Otc medication manufactured, distributed, or labeled by RELIABLE 1 LABORATORIES, GCP Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Use

relieves the symptoms referred to as gas

Warnings

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

• shake well before using
• all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
• only use the enclosed dropper
• do not exceed 12 doses per day
• fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
• dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
• clean dropper well after each use and replace original cap on bottle

Age (years)	Weight (lbs)	Dose
infants (under 2)	under 24	0.3 mL
children (2 and over)	24 and over	0.6 mL

Other information

• TAMPER-EVIDENT: Do not use if foil seal under the cap is broken or missing.
• store between 20°-25°C (68°-77°F)
• do not freeze
• see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

call 516-341-0666
8:30 am - 4:30 pm ET,
Monday - Friday

package Label

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF DROPS 
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-059
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (off-white)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-059-51	1 in 1 CARTON	02/01/2020
1		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 Drug	M002	02/01/2020

Labeler - RELIABLE 1 LABORATORIES (079718111)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(69618-059)