MedPath
HSA Approval

OTRIVIN NASAL SPRAY 0.1%

SIN11624P

OTRIVIN NASAL SPRAY 0.1%

OTRIVIN NASAL SPRAY 0.1%

August 14, 2001

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.
Licence HolderGSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

SPRAY

**How should Otrivin 0.1% be used?** Unless otherwise prescribed by the doctor, always give Otrivin 0.1% exactly as recommended below. Do not exceed the recommended dosage, especially in children and the elderly. You should check with your doctor or pharmacist if you are not sure. Do not exceed 3 applications daily into each nostril. It is recommended to make the last application shortly before retiring to bed. The usual doses are as follows: ![Otrivin Nasal Spray Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/f3e79f2bb889bdf45f53f9275ff5a4a6.png) To produce a fine spray, the squeeze bottle should be held upright with the nozzle pointing upwards. Be careful not to spray in the eyes. 1. Clear your nose. 2. Remove protective cap 3. Lean forward slightly and insert the nozzle into a nostril. 4. Squeeze the bottle once and breathe in gently at the same time. ![Otrivin Nasal Spray Dosage Image 1](https://cdn.medpath.com/drug/dosage/20240520/1f50d49c575d24a14491df9feff4cec4.png) 5. Remove the nozzle before releasing the pressure on the bottle. 6. Repeat with the other nostril. 7. Clean and dry the nozzle before replacing back the cap right after use. 8. To avoid possible spread of infection, the spray should only be used by one person. Please keep to the doses which appear in the package leaflet or prescribed by your doctor. If you feel that the medicinal product is not effective enough or on the contrary, it is too effective, please consult your doctor or pharmacist. Like other nasal decongestants, Otrivin 0.1% should not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use may cause stuffiness in the nose to return or worsen.

NASAL

Medical Information

**What is Otrivin 0.1% and when is it used?** Otrivin 0.1% is a clear, colourless and practically odourless solution containing 1mg/mL of xylometazoline hydrochloride. It quickly decongests your stuffy nose and helps clear blocked mucus secretions so you can breathe easier. Otrivin 0.1% is used for various types of colds. It is designed to be applied in the nostrils,where it exerts a vasoconstricting effect thereby decongesting the mucosae of the nose and the throat. This effect allows patients with colds to breathe more easily through the nose. The action of Otrivin 0.1% is felt within 2 minutes and lasts for several hours. Otrivin 0.1% contains ingredients which help prevent the nasal mucosa from drying out. Otrivin 0.1% is indicated in adults and in adolescents over 12 years of age.

**When must Otrivin 0.1% not be used?** **Do not use Otrivin 0.1% if:** - you are allergic to xylometazoline or any other ingredients of this medicine - you have undergone recent trans-nasal surgery (brain surgery where the operation was carried out through the nose or mouth) - you have narrow angle glaucoma (increased pressure in eyes) - you have chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis) - the child is below 12 years of age Tell your doctor or pharmacist if any of the above apply because Otrivin 0.1% is not suitable for use in these circumstances.

R01AA07

xylometazoline

Manufacturer Information

gsk consumer healthcare singapore pte. ltd.

GSK Consumer Healthcare SARL

Active Ingredients

XYLOMETAZOLINE HCl

1 mg/ml

Xylometazoline

Documents

Patient Information Leaflets

OTRIV SPR 0.1% F5 10 ML SEA PIL.pdf

Approved: September 8, 2021

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OTRIVIN NASAL SPRAY 0.1% - HSA Approval | MedPath