Important Product Information:
Paracetamol, Phenylephrine HCL, Diphenhydramine HCL & Caffeine Tablets
Coldarin All in 1®
1. What is this medicine and what is it used for?
This medicine contains:
Paracetamol which is a pain reliever
Phenylephrine hydrochloride which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily
Diphenhydramine hydrochloride, which is a antihistamine used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by common cold. Diphenhydramine hydrochloride is also used to relieve cough caused by minor throat or airway irritation
Caffeine which helps to increase the pain relief from paracetamol and makes you more alert.
These Tablets are used for relief from common cold and flu symptoms such as head and body ache, sneezing, runny nose, nasal congestion, sore throat and cough.
What you need to know before you take medicine?
Do not take this medicine if you:
・are allergic to paracetamol, phenylephrine, caffeine and diphenhydramine chloride or any of the other ingredients
・are under 12 years of age
・have a serious heart condition or cardiovascular disorder(s)
・have high blood pressure (hypertension)
・have an overactive thyroid
・have an enlarged prostate or other prostate problems
・are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days
Please see your doctor or pharmacist before taking this medicine if you:
・suffer from kidney or liver problems, including alcoholic liver disease or have alcohol dependence
・have a blood vessel disease such as Raynaud’s phenomenon
・Have heart or circulation disease.
If you are taking any of the following medicines please see your doctor:
・medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine
・medicines to control feeling sick or being sick such as metoclopramide or domperidone
・medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins-you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis
・medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers(for example atenolol),methyldopa, or ganglion blocking agents (for example trimetaphancamsylate).
・particularly tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs prescribed for depression) within the last two weeks,
・atropine (used to dilate pupils of the eyes) or medicines which make you drowsy.
・Avoid the use of other antihistamines including those used on your skin and in cold and cough medicines, while taking this medicine.
・Do not drink alcohol while taking this medicine
Special Warnings and Precautions
・Limit use of caffeine-containing medications, food, and beverages.
・Patients with the following conditions should be advised to consult a physician before using diphenhydramine: a respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma ; glaucoma, prostate hyperplasia with urinary retention.
・Paracetamol overdose warning: Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, get medical help immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
・Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol.
・Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
・Chronic alcohol users should ask their physician whether they should take paracetamol or other pain relievers or fever reducers.
・This medicine may cause drowsiness.
・Patients with heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination and/or enlargement of the prostate should not take phenylephrine unless directed by a physician.
・Diphenhydramine may enhance the sedative effects of central nervous system
・The sedative effects as well as the antimuscarinic properties of diphenhydramine, which may be responsible for altering the secretions in the airways, may result in cough suppression.
・depressants including alcohol, sedatives, and tranquilizers. While taking this product, avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants
・Do not use this product for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.
・If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.
Pregnancy, breast feeding and fertility
Talk to your doctor before taking medicine if you are pregnant, trying to become pregnant or breast feeding.
Driving and using machines
Do not drive or operate machinery
Do not take anything else containing paracetamol or Diphenhydramine while taking this medicine.
3. How to take this medicine
Always take this medicine exactly as mentioned or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablet whole with water. Do not chew.
Take one tablet every 4 to 6 hours; not to exceed a maximum daily dose of 6 tablets within 24 hour period.
Do not use in children below 12 years of age.
Do not take more than the recommended dose
4. Possible side effects
Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.
Stop taking this medicine and tell your doctor immediately if you experience:
・The most common side effects are tiredness, drowsiness, reduced attention, unsteadiness, dizziness or a dry mouth
・Not known (frequency cannot be estimated from the available data)
・Allergic reactions (such as rash, shortness of breath and swelling), blurred vision, palpitations (feeling your heart beat) or irregular heartbeat.
・Muscle twitching, convulsions, headache or pins and needles.
・Also nausea (feeling sick), vomiting (being sick), thicker bronchial mucus and difficulty passing urine
5. How to store your medicine
Store at ambient temperature.
Keep out of reach of children.
M/s Unique Pharmaceutical Laboratories.
A division of J.B.Chemicals & Pharmaceuticals Ltd.,
Survey No. 101/2 & 102/1, Daman Industrial Estate,
Airport Road, Village Kadaiya, Daman 396210, India.
Johnson & Johnson Pvt. Ltd.,
L.B.S. Marg, Mulund (W), Mumbai 400080.
Date of Revision: 8 September 2021.