Fridababy Gas Drops Simethicone antigas

Fridababy FartFreeing Gas Drops 6ct 0.13mLea by

Drug Labeling and Warnings

Fridababy FartFreeing Gas Drops 6ct 0.13mLea by is a Otc medication manufactured, distributed, or labeled by Fridababy LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRIDABABY FARTFREEING GAS DROPS 6CT 0.13MLEA- simethicone 20mg suspension 
Fridababy LLC

----------

Fridababy Gas Drops Simethicone antigas

Active Ingredient (in each 0.3 mL)

Simethicone 20mg (provided as simethicone emulsion 66.7mg)

Purpose

Antigas

Uses

■ 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.

Keep out of reach of children

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

Directions

■ shake well before using

■ use the chart below to confirm the dose. If possible, use weight to determine dose; otherwise, use age

■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician

■ do not give more than 12 doses per day

■ give the recommended number of vials below, following the instructions: 1) tap the tip of the vial to eliminate air bubbles, 2) twist the tip of the vial off 3) squeeze the liquid into child’s mouth

■ residual liquid in the vial after dosing is normal and expected.

■ mL = milliliter

Dosing Chart

Age (years)	Weight (lbs)	Dose (mL)
Infants under 2	Under 24	1 Single-Use Vial (0.3mL)
Children 2 and over	24 and over	2 Single-Use Vials (0.6mL)

Other Information

■ do not freeze

■ store at 20-25°C (68-77°F)

■ tamper-evident: do not use if tamper evident tape is broken or missing. Do not use if any vial is open or broken

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, purified water, sodium benzoate, sucralose, trisodium citrate, xanthan gum

Questions or Comments?

1-833-WTF-FRIDA (1-833-983-3743)

Package

FRIDABABY FARTFREEING GAS DROPS 6CT 0.13MLEA 
simethicone 20mg suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72705-110
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72705-110-06	6 in 1 CARTON	08/31/2022
1		0.3 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 72705-110-10	10 in 1 POUCH	08/31/2022
2		0.3 mL in 1 VIAL; 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	08/31/2022	08/31/2022

Labeler - Fridababy LLC (783729598)

Revised: 12/2023

Document Id: 0c947089-038b-d026-e063-6294a90af1bb

34390-5

Set id: d5532293-71e7-f1f8-e053-2a95a90a850a

Version: 4

Effective Time: 20231215