EXTRA STRENGTH GAS RELIEF- simethicone liquid
Raritan Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NuRelief Extra Strength Gas Relief Liquid

Active Ingredient (in each 5 mL)

Simethicone 125 mg

Purpose

Antigas

Uses

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.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms.

Directions

▪: shake well before using
▪: do not take more than 20 mL in any 24-hour period except under the advice and supervision of a physician
▪: measure only with dosing cup provided
▪: do not use dosing cup with other products
▪: mL = milliliter
▪: adults: 5 mL or 10 mL in dosing cup provided as needed after meals and at bedtime.
▪: do not exceed 4 softgels in 24 hours unless directed by a doctor

Other information

•: store at room temperature
•: do not refrigerate
•: protect from light, heat, and moisture

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, glycerin, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, sucralose, xanthan gum.

Questions or comments?

Call 1-866-467-2748

Principal Display Panel

SAFE AND EFFECTIVE RELIEF

NuRelief™

NDC# 68163-700-08

Relieves Gas, Bloating & Abdominal Discomfort

EXTRA STRENGTH

Gas relief liquid

Simethicone 125mg/Anti-Gas

FAST RELIEF

Relives Gas, bloating & Abdominal Discomfort

DYE & SUGAR FREE

Tropical Fruit Flavor

Naturally Flavored

48 DOSES

Dosage cup Included

8 FL OZ (237 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by Lifelab Health LLC

5300 W Hillsboro Blvd, Suite 202

Coconut Creek, FL 33073

www.NuRelief.com

MADE IN USA

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

NuRelief Gas Relief Liquid Tropical Fruit

EXTRA STRENGTH GAS RELIEF
simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68163-700
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68163-700-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	08/26/2020

Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2020

Document Id: cd7d7784-d4b6-4116-95ff-886b15b7c36c

Set id: 9af45664-adf4-49ce-987d-9314e9804a29

Version: 2

Effective Time: 20200918

Raritan Pharmaceuticals Inc