Tablet Ref.[27537] Active ingredients: Naproxen

Source: Health Products and Food Branch (CA) Revision Year: 2021

Product name

ALEVE Caplets.

ALEVE Liquid Gels.

ALEVE Back and Body Pain.

Summary product information

Route of Administration	Dosage Form / Strength	Clinically Relevant Nonmedicinal Ingredients
Oral	Caplets, Capsules, Tablets 220mg	For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph

Dosage forms, composition and packaging

One caplet/tablet of ALEVE Caplets contains naproxen sodium 220 mg, of which 20 mg is sodium. The excipients consist of FD&C Blue No. 2 Aluminium Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide and talc. Packaging consists of:

Clear polyvinyl chloride (PVC) blisters with aluminium foil backing packed into an outer carton containing 6 caplets.
Opaque HDPE bottles containing 24, 50, 100, 170 or 250 caplets packed into an outer carton.

One capsule of ALEVE Liquid Gels and ALEVE Back and Body Pain contains naproxen sodium 220 mg, of which 20 mg is sodium. The excipients consist of FD&C Blue No. 1, gelatin, glycerin, hypromellose, lactic acid, mannitol, polyethylene glycol, povidone, propylene glycol, sorbitan, sorbitol, titanium dioxide, water. Packaging consists of:

ALEVE Liquid Gels:

Opaque HDPE bottles containing 20, 40, 80 capsules packed into an outer carton.
Opaque HDPE bottle containing 160 capsules.

ALEVE Back and Body Pain:

Opaque HDPE bottles containing 26, 52 or 57 capsules packed into an outer carton.

Marketing Informations	Authorization Dates
Authorization holder: Bayer Inc., 2920 Matheson Boulevard East, Mississauga, ON L4W 5R6 Submission control number: 243112	Date of revision: January 14, 2021

Drugs

Drug	Countries
ALEVE	Austria, Canada, Germany, Hong Kong, Malta, Netherlands, Poland, Singapore, Turkey, South Africa

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