GAS RELIEF SIMETHICONE 125MG SOFTGEL- simethicone capsule, liquid filled

Active Ingredient (in each softgel)

Simethicone 125 mg
Purpose

Antigas
Use

Use for the relief of pressure, bloating, and fullness, commonly referred to as gas.
Warnings

If pregnant or breast-feeding, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
- store at 15° to 30°C (59° to 86°F)
- protect from light, heat, and moisture
Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).
Questions or Comments?

Call 1 (718) 337-8733 or visit support@nuvicare.com
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GAS RELIEF SIMETHICONE 125MG SOFTGEL
simethicone capsule, liquid filled

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
PEPPERMINT OIL (UNII: AV092KU4JH)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 84324-014-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M002	07/18/2024

Labeler - NUVICARE LLC (119257565)

Registrant - NUVICARE LLC (119257565)

Gas Relief Simethicone 125mg Softgel by