Congestal
Generic name :
Paracetamol (acetaminophen)
Chlorpheniramine maleate
Pseudoephedrine hydrochloride
Composition :
Each tablet contains:
Active ingredients:
Acetaminophen (Paracetamol) 650 mg
Chlorphenirarnine maleate 4 mg
Pseudoephedrine HCL 60 mg
Inactive ingredient: Povidone K30, Corn starch (Maize starch), Croscarmellose sodium, Talc, Colloidal Silicon dioxide (Aerosil 200),Magnesium stearate.
Pharmaceuticat form :
Tablets
Mechanism of action :
Congestal combine the action of its ingredients
as follow:
– Acetaminophen acts as pain reliever and fever reducer.
– Chlorpheniramine maleate acts as antihistamine -Pseudoephedrine hydrochloride acts as nasal decongestant.
Indications :
Congestal is indicated for:
Relieving these symptoms of hay fever and the common cold:
– runny nose and sneezing
– nasal congestion
– minor aches and pains
– headache
– sinus congestion and pressure
Relieving these additional symptoms of hay fever:
– itching of the nose or throat
– itchy, watery eyes -helps clear nasal passafles
Dosage and administration :
Do not exceed recommended dosage.
Adults and children 12 years and over: take one tablet every 4-6 hours • swallow whole – do not crush, chew or dissolve
• do not take more than 6 tablets in 24 hours.
Contra indications :
Hypersensitivity to any of ingredients of Congestal tablets.
Drug interactions :
Congestal tablets should not be used with:
• Any other drug containing acetaminophen (prescription or non-prescnption). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• Monoamine oxidase inhibitor (MAOI) (certain drugs for depression, ps>,chiatnc or emotional conditions, or Parkinson s disease), or for 2 weeks after stopping the MAOI drug. If you do
not know if your prescribed drugs contain an MAO I , ask a doctor or pharmacist before giving this product.
Precautions and warnings :
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen. .3 or more alcoholic drinks every day while using this product.
Congsetal tablets should not be used to make a child sleepy.
Ask a doctor before use if you have :
– liver disease
– heart disease
– glaucoma
– thyroid disease
– high blood pressure
– trouble urinating due to an enlarged prostate gland
– a breathing problem such as emphysema or chronic bronchitis
– diabetes
Ask a doctor or pharmacist before use if you are :
– taking sedatives or tranquilizers
– taking the blood thinning drug warfarin
When using this product :
– do not use more than directed
– excitability may occur, especially in children
– alcohol, sedatives and tranqullizers may increase drowsiness
– avoid alcoholic drinks
– be careful when driving a motor vehicle or operating machinery
– drowsiness may occur
Stop use and ask a doctor if :
– new symptoms occur
– you get nelVOUS, dizzy or sleepless
– pain or nasal congestion gets worse or lasts more than 7 days
– redness or swelling is present
– fever gets worse or lasts more than 3 days These could be signs of a serious condition.
– If pregnant or breast-feeding,
– Ask a health professional before use. In case of overdose. get medical help.
Patient Instructions :
Keep out of reach of children.
Package and storage :
A carton box containing 1 or 2 (AI/opaque white PVC)
blisters each of 10 tablets + insert leaflet.
Store in dry place at temperature not exceeding 25° C.
produced by :
sigma pharmaceutical industries egypt . s.a.e
