Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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DRISTAN* TABLETS SCHEDULING STATUS: S2 PROPRIETARY NAME: (and dosage form) DRISTAN* TABLETS ACTIVE INGREDIENTS: Each tablet contains: Aspirin 325,00 mg Phenylephrine Hydrochloride 5,00 mg Chlorpheniramine Maleate 2,00 mg Caffeine 16,20 mg INDICATIONS: DRISTAN* Tablets are indicated for the relief of symptoms associated with colds and influenza such as nasal congestion, headache, aches and pains, fever and hayfever. WARNINGS: This medicine may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other C.N.S. depressant agents. If symptoms do not improve within 7 days or are accompanied by high fever, discontinue use and consult a doctor. Excessive and prolonged use of this medicine may be dangerous. Aspirin [acetyl salicylic acid] has been implicated in Reye's syndrome, a rare but serious illness in children and teenagers with chicken pox and influenza. A doctor should be consulted before Aspirin is used in such patients. The safety of this preparation in pregnant women, or nursing women, has not been established. STORAGE INSTRUCTIONS: Store below 25 °C. Protect from light. KEEP OUT OF REACH OF CHILDREN. DOSAGE AND DIRECTIONS FOR USE: Adults Two tablets 3 to 4 times daily. Children [6-12] One tablet 3 times daily. Not recommended for children under the age of 6 years. Do not exceed 8 tablets in 24 hours. REFERENCE NUMBER: C.717 [Act 101/1965] NAME AND BUSINESS ADDRESS OF APPLICANT: S.A.D. SELF MEDICATION [PTY] LIMITED [Co. Reg. No. 92/04769/07] Robbie de Lange Road, Wilsonia, EAST LONDON, 5201 Read the complete document