Otrivin Paed. Nasal Metered-Dose Spray

The effect of Otrivin sets in within a few minutes and persists for several hours. Otrivin Paed. Nasal Metered Dose-Spray

Ingredients and Instructions for use

Otrivin Paed Nasal Metered Dose Spray is contraindicated in children aged less than 2 years old. Otrivin Paed should be used in children aged 2 to 11 years old only under adult supervision. Ingredients: Otrivin Paed 0.05% MD Spray contains xylometazoline hydrochloride, the number one nasal decongestant. It rapidly relieves nasal congestion by locally constricting blood vessels in the nasal mucosa, reducing the swelling and opening the airways. It also facilitates drainage of the openings that connect the sinuses to the nasal cavity to ensure they remain open. 1 ml contains 0,5 mg of xylometazoline hydrochloride. Preservative: 0,011 % m/v benzalkonium chloride.

How to use Otrivin Paed. Nasal Metered Dose Spray

Otrivin Paed. Nasal Drops and Otrivin Paed. Nasal Metered-Dose Spray (0,5 mg/ml) are for nasal administration only, for children aged 2 up to 12 years of age

1 to 2 drops of the 0, 5 mg/ml solution or one puff of the metered-dose spray into each nostril, once or twice daily, are generally sufficient. A total of 2 applications a day should not be exceeded.

Before the first application, prime the pump by actuating 4 times. Once primed, the pump will normally remain charged throughout regular daily treatment periods. If the spray is not ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump for the Otrivin Paed Nasal Metered-Dose Spray will need to be reprimed with 2 actuations and the pump for the nose.
Safety Information

Excessive administration of Otrivin or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.

In instances of accidental poisoning in children, the clinical picture may be marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness, sweating, drowsiness, coma, convulsions, circulatory collapse.
How to Store Otrivin Paed. Nasal Metered Dose Spray

Store at or below 25 °C. Keep out of the reach of children.Do not use the product after the expiry date shown on the

packaging.

Promotion of Access to Information Act (PAIA)

The PAIA manual is prepared in accordance with section 51 of the Promotion of Access to Information Act (PAIA) No. 2 of 2000 (as amended) and the Protection of Personal Information Act, 2013. The purpose of PAIA is to promote the right of access to information, to foster a culture of transparency and accountability within the Company by giving the right to information that is required for the exercise or protection of any right and to actively promote a society in which the people of South Africa have effective access to information to enable them to exercise and protect their rights.

Please see the PAIA manual.

S1 Otrivin Adult Drops. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01 % m/v. Reg. no.: H/16.1/1382.
S1 Otrivin Adult Nasal Metered-dose Spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01 % m/v. Reg. no.: H/16.1/1382.

* class-specific comparison (topical vs systemic decongestant)

Ref 1. Eccles R. Over the counter medicines for colds. In: Common Cold. Eccles R & Weber O, eds. Basel, Switzerland: Birkhäuser Verlag; 2009. (see reference here)

Ref 2. Eccles R, Eriksson M, Garreffa S, et al. The nasal decongestant effect of xylometazoline in the common cold. Am J Rhinol. 2008;22(5):491–6 (see reference here)

S1 OTRIVIN Menthol Nasal Metered-dose Spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01% m/v. Reg. no.: 31/16.1/0319.
S1 OTRIVIN Paed. Drops. Each 1 ml contains 0,5 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01 % m/v. Reg. no.: H/16.1/1381.
S1 OTRIVIN Paed. Nasal Metered-dose Spray. Each 1 ml contains 0, 5 mg of xylometazoline hydrochloride. Preservative: Benzalkonium chloride 0.01 % m/v. Reg. no.: H/16.1/1381.
Otrivin Sea Water with Aloe Vera Nasal Spray / Otrivin Sea Water with Eucalyptus Nasal Spray /
Otrivin Baby Care - Moisturising Nasal Spray

Applicant: GlaxoSmithKline Consumer Healthcare South Africa (Pty) Limited, 39 Hawkins Avenue, Epping Industria 1, Cape Town, 7460.

Company reg. no.: 2014/173930/07. For full prescribing information refer to the professional information approved by the medicines regulatory authority. Always read label prior to use.

For any further information, including safety and adverse reactions, please contact the GSK Hotline on 0800 007 018 or mystory.za@haleon.com.

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