INFANTS GAS RELIEF- simethicone suspension/ drops

INFANTS GAS RELIEF by

Drug Labeling and Warnings

INFANTS GAS RELIEF by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 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 (1-800-222-1222) 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
• do not exceed 12 doses per day
• fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
• may be mixed with 1 oz of cool water, infant formula or other suitable liquid
• clean dropper well after each use and replace original cap

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

• store at room temperature
• do not freeze
• see bottom panel for lot number and expiration date
• TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing

Inactive ingredients

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

Questions or comments?

1-800-540-3765

package Label

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF 
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0423
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0423-1	1 in 1 CARTON	01/01/2019
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 final	part332	01/01/2019

Labeler - Cardinal Health (097537435)

Registrant - GCP Laboratories (965480861)

Establishment
Name	Address	ID/FEI	Business Operations
GCP Laboratories		965480861	manufacture(70000-0423)