Throat Lozenges Monograph Monograph

Accepted Names (English)

54

Benzocaine(common)Benzyl alcohol(common)Cetylpyridinium chloride(antiseptic)(common)Dequalinium chloride (antiseptic)(common)Domiphen bromide(antiseptic)(common)Dyclonine hydrochloride(common)Eucalyptus essential oil(common)Eucalyptus globulus leaf essential oil(common)Fruit(common)Fruit peel(common)Gelatin(common)Hexylresorcinol(common)Hexylresorcinol (analgesic/anesthetic/antiseptic)(common)Mentha arvensis(common)Mentha canadensis(common)Mentha x piperita(common)Menthol(common)Partially hydrolyzed collagen(common)Pectin(common)Phenol(common)Racemic Menthol(common)Red elm(common)Salicyl alcohol(common)Slippery elm(common)dl-Menthol(common)l-Menthol(common)(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexanol(proper)(1R,2S,5R)-5-Methyl-2-(propan-2-yl)cyclohexan-1-ol(proper)(1R,2S,5R)-rel-5-Methyl-2-(1-methylethyl)-cyclohexanol(proper)(1RS,2RS,5RS)-(±)-5-Methyl-2-(1-methylethyl)cyclohexanol(proper)1,1'-(1,10-Decanediyl)bis-(4-amino-2-methylquinolinium chloride)(proper)1,1'-Decamethylenebis(4-aminoquinaldinium chloride)(proper)1-Hexadecylpyridinium chloride(proper)2-Hydroxybenzenemethanol(proper)4-Aminobenzoic acid, ethyl ester(proper)4-Hexyl-1,3-benzenediol(proper)4-Hexylresorcinol(proper)4-n-Butoxy-beta-(1-piperidyl)propiophenone hydrochloride(proper)Citrus limon(proper)Citrus maxima(proper)Citrus paradisi(proper)Citrus reticulata(proper)Citrus sinensis(proper)Dodecyldimethyl(2-phenoxyethyl)ammonium bromide(proper)Eucalyptus globulus(proper)Gelatin(proper)Malus domestica(proper)N,N-Dimethyl-N-(2-phenoxyethyl)-1-dodecanaminium bromide(proper)Pectin(proper)Phenol(proper)Ulmus rubra(proper)alpha-Hydroxytoluene(proper)dl-Menthol(proper)l-Menthol(proper)

Accepted Names (French)

54

Benzocaine(common)Benzyl alcohol(common)Cetylpyridinium chloride(antiseptic)(common)Dequalinium chloride (antiseptic)(common)Domiphen bromide(antiseptic)(common)Dyclonine hydrochloride(common)Eucalyptus essential oil(common)Eucalyptus globulus leaf essential oil(common)Fruit(common)Fruit peel(common)Gelatin(common)Hexylresorcinol(common)Hexylresorcinol (analgesic/anesthetic/antiseptic)(common)Mentha arvensis(common)Mentha canadensis(common)Mentha x piperita(common)Menthol(common)Partially hydrolyzed collagen(common)Pectin(common)Phenol(common)Racemic Menthol(common)Red elm(common)Salicyl alcohol(common)Slippery elm(common)dl-Menthol(common)l-Menthol(common)(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexanol(proper)(1R,2S,5R)-5-Methyl-2-(propan-2-yl)cyclohexan-1-ol(proper)(1R,2S,5R)-rel-5-Methyl-2-(1-methylethyl)-cyclohexanol(proper)(1RS,2RS,5RS)-(±)-5-Methyl-2-(1-methylethyl)cyclohexanol(proper)1,1'-(1,10-Decanediyl)bis-(4-amino-2-methylquinolinium chloride)(proper)1,1'-Decamethylenebis(4-aminoquinaldinium chloride)(proper)1-Hexadecylpyridinium chloride(proper)2-Hydroxybenzenemethanol(proper)4-Aminobenzoic acid, ethyl ester(proper)4-Hexyl-1,3-benzenediol(proper)4-Hexylresorcinol(proper)4-n-Butoxy-beta-(1-piperidyl)propiophenone hydrochloride(proper)Citrus limon(proper)Citrus maxima(proper)Citrus paradisi(proper)Citrus reticulata(proper)Citrus sinensis(proper)Dodecyldimethyl(2-phenoxyethyl)ammonium bromide(proper)Eucalyptus globulus(proper)Gelatin(proper)Malus domestica(proper)N,N-Dimethyl-N-(2-phenoxyethyl)-1-dodecanaminium bromide(proper)Pectin(proper)Phenol(proper)Ulmus rubra(proper)alpha-Hydroxytoluene(proper)dl-Menthol(proper)l-Menthol(proper)

Approved Health Claims

10

For temporary relief of (minor) sore throat
Temporarily relieves/soothes (minor) sore throat
For temporary relief of pain of (minor) sore throat
Temporarily relieves/soothes pain of (minor) sore throat
For (the) protection of irritated area in the throat
Protects irritated areas in the throat
Helps ease/relieve nasal congestion
Makes nasal passages feel clearer
For (the) temporary relief of coughs
Temporarily relieves/soothes coughs

Approved Health Claims (Français)

10

For temporary relief of (minor) sore throat
Temporarily relieves/soothes (minor) sore throat
For temporary relief of pain of (minor) sore throat
Temporarily relieves/soothes pain of (minor) sore throat
For (the) protection of irritated area in the throat
Protects irritated areas in the throat
Helps ease/relieve nasal congestion
Makes nasal passages feel clearer
For (the) temporary relief of coughs
Temporarily relieves/soothes coughs

Cautions & Contraindications

16

cautionAll products

cautionKeep out of reach of children. In case of overdose, call a poison control centre or get medical help right away.

cautionProducts including claim for the temporary relief of (minor) sore throat and/or temporary relief of pain of (minor) sore throat and/or irritated throat (except for products containing benzocaine)

cautionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if sore throat worsens or persists for more than 2 days.

cautionProducts including claim for the temporary relief of coughs

cautionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if cough worsens and persists for more than 7 days, or is accompanied by a fever.

cautionProducts containing ingredients in Tables 4 or 5

cautionAsk a doctor/physician/health care practitioner/health care provider/health care professional before use if you are pregnant or breastfeeding.

cautionProducts containing benzocaine

cautionWhen using this product do not chew gum or food while numbness persists (USP DI 2006; CPhA 1996).

cautionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if sore throat is severe, persists for more than 2 days, or is accompanied by or followed by other symptoms such as fever, headache, rash, swelling, nausea, or vomiting (Pray 2006; USP DI 2006; US FDA 1994).

contraindicationProducts containing benzocaine

contraindicationDo not use if you are allergic to benzocaine.

adverse_reactionProducts containing benzocaine

adverse_reactionStop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if the following symptoms appear: weakness, confusion, headache, difficulty breathing and/or pale, gray or blue coloured skin. These symptoms may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use (US FDA 2018; US FDA 2011a,b; HC 2006).

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Ingredients Covered

30

Throat Lozenges Monograph