EXTRA STRENGTH GAS RELIEF- simethicone liquid

EXTRA STRENGTH by

Drug Labeling and Warnings

EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 advise 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

citric acid, carboxymethylcellulose sodium, glycerin, microcrystalline cellulose, natural pineapple coconut flavor, potassium sorbate, purified water, sodium benzoate, sorbitol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

Call 1-866-467-2748

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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

Pinacolada Flavor

Naturally Flavored

Dye & Sugar Free

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

6574 N. State Road # 7 361, 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.

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH  GAS RELIEF
simethicone liquid

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-700-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/28/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)