REACTINE Tablet, Capsule, Syrup Ref.[27789] Active ingredients: Cetirizine

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

Product name

REACTINE – Cetirizine hydrochloride.

Summary product information

Route of AdministrationDosage Form/StrengthClinically Relevant Nonmedicinal Ingredients
OralNon-prescription: Film-coated tablets 5 mg, 10 mg
Orally disintegrating tablets, 10 mg
Soft gelatin capsules, 10 mg
Syrup 5 mg/5 mL (sugar-free)
Prescription: Film-coated tablet 20 mg
Film-coated tablets: lactose
Soft gelatin capsules: sorbitol
Sugar-free grape flavour syrup: sodium benzoate, sorbitol and sucralose
For a complete listing see Dosage Forms, Composition and Packaging section.

Dosage forms, composition and packaging

REACTINE (cetirizine hydrochloride) Film-coated Scored Tablet: 5, 10, and 20 mg of cetirizine hydrochloride.

The 20 mg tablets are only available by prescription. For commercial use, tablet packaging: 10 mg tablets, plastic bottles of 100 For OTC use, tablet packaging: 5 mg blister packages of 36 tablets 10 mg blister packages of 3, 10, 30, 48 and 84 tablets

For prescription use, tablet packaging: 20 mg tablets, plastic bottles of 100

Cetirizine hydrochloride is formulated in white (dye-free), film-coated, scored ovoid tablets and is available in 5, 10, and 20 mg strengths. Non-medicinal ingredients include: corn starch, hypromellose, lactose, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. May or may not contain carnauba wax.

REACTINE (cetirizine hydrochloride) FAST MELT Junior Orally Disintegrating Tablets: 10 mg of cetirizine hydrochloride.

For OTC use, tablet packaging: 10 mg blister packages of 12 and 24 tablets.

Cetirizine hydrochloride (10 mg) orally disintegrating tablets are white to off-white, round, flat-faced, beveled edge tablets in a 10 mg strength. Non-medicinal ingredients include: Amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavours, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose.

REACTINE (cetirizine hydrochloride) Rapid Dissolve Orally Disintegrating Tablets:10 mg of cetirizine hydrochloride.

For OTC use, tablet packaging: 10 mg blister packages of 24 tablets.

Cetirizine hydrochloride (10 mg) orally disintegrating tablets are white to off-white, round, flat-faced, beveled edge tablets in a 10 mg strength. Non-medicinal ingredients include: Amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavours, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose.

REACTINE (cetirizine hydrochloride) Allergy Liquid Gels Capsules: 10 mg of cetirizine hydrochloride.

For OTC use, capsule packaging: 10 mg plastic bottles of 25 and 40 capsules.

REACTINE Allergy Liquid Gels capsules are formulated as clear, oval, liquid filled soft gelatin capsules, available in a 10 mg strength. Non-medicinal ingredients include: gelatin, glycerin, lecithin, mannitol, medium chain triglycerides, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol.

REACTINE and REACTINE Allergy (cetirizine hydrochloride) Sugar-free Syrup: Each 5 mL contains 5 mg cetirizine hydrochloride. It is supplied in 118 mL polypropylene bottles. REACTINE (cetirizine hydrochloride) syrup is sugarless and colourless with a grape flavour. Non-medicinal ingredients include: anhydrous citric acid, flavours, propylene glycol, purified water, sodium benzoate, sorbitol solution and sucralose.

Marketing Informations Authorization Dates
Authorization holder:

McNeil Consumer Healthcare, division of Johnson & Johnson Inc., 88 McNabb Street, Markham, Canada, L3R 5L2

Submission control number:

246339

Date of revision:

March 18, 2021

Drugs

Drug Countries
REACTINE Brazil, Canada, Germany, France, Netherlands

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