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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.

Applicant: Haleon South Africa (Pty) Ltd. 11 Hawkins Avenue, Epping Industria 1, Cape Town,7450.

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 Haleon Hotline on 0800 007 018 or mystory.za@haleon.com.

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PM-ZA-OTRI-21-00023