Cold Control Tablet is used to treat common cold symptoms. It provides temporary relief from stuffiness in the nose. It also helps to relieve allergy symptoms like runny nose and watery eyes. Cold Control Tablet is taken with or without food in a dose and duration as advised by the doctor. It is better to take it with food to avoid stomach upset. Let your doctor know about all other medications you are taking as some may affect, or be affected by this medicine.

The most common side effects are nausea, stomach pain, drowsiness, coordination impaired, and headache. Most of these are temporary and usually resolve with time. Contact your doctor straight away if you are at all concerned about any of these side effects. It can also cause dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you. Avoid drinking alcohol while taking this medicine as it can make dizziness worse.

Before taking it, you should tell your doctor if you have any kidney or liver diseases so that your doctor can prescribe a suitable dose for you. Also tell your doctor if you are pregnant, planning pregnancy or breastfeeding.

• Company name: Egyptian Group for Pharmaceutical Industries (EGPI).
• Trade name: Cold Control Film coated tablets.
• Generic name: Acetaminophen 500 mg + Diphenhydramine HCI 12.5 mg.
• Pharmaceutical form: Film Coated Tablets.

Composition

Active Ingredients:

• Acetaminophen 500 mg.
• Diphenhydramine HCI 12.5 mg.

Inactive ingredients: Croscarmellose sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene glycol, Titanium dioxide, Talc, FD&C Yellow # 6.

Indications

Runny nose, sneezing, headache, minor aches and pains, itching of the nose or throat and itchy, watery eyes due to hay fever.

Dosage & Administration

• Adults & Children 12 years and over: Take 2 F.C.Tablets every 4 to 6 hours; not more than 8 F.C.Tablets in 24 hours.
• Children below 12 years: Do not use this adult product.

Contraindications

• With any other product containing acetaminophen or diphenhydramine.
• Cold Control is contraindicated to patients are now taking a prescription Monamine oxidase inhibitors (MAOI), or for 2 weeks after stopping the MAOI drug.
• Do not use below age of 12 years.

Side effects

May cause some sedative effects as drowsiness, in-coordination. These sedative effects when they occur may diminish after a few days of treatment.

Instructions to patients

• Do not use below age of 12 years.
• Be careful when driving a motor vehicle or operating machinery.
• Taking more than the recommended dose (overdose) may cause liver damage.

Stop drug if:

• Pain gets worse or lasts more than 10 days.
• Fever gets worse or lasts more than 3 days.
• Redness or swelling is present.
• New symptoms occur.

Pharmacological action

Acetaminophen is a pain reliever and fever reducer. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulation center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness.

Diphenhydramine HCL is an Antihistaminic which helps provide temporary relief of itchy, watery eyes, runny nose, sneezing, itching of the nose or throat due to hay fever or other respiratory allergies.

Pharmacokinetics

Acetaminophen is readily absorbed from gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses. It is distributed into most body tissues. It is metabolized predominantly in the liver. The elimination half life varies from about 1 to 3 hours. It is excreted in the urine.

Diphenhydramine hydrochloride is well absorbed from gastrointestinal tract with peak plasma concentrations occurring about 1 to 4 hours after oral doses. It is widely distributed throughout in the body including the CNS. It is highly bound to plasma proteins. The elimination half life varies from about 2.4 to 9.3 hours. It is excreted in the urine.

Drug Drug interactions

• Monamine oxidase inhibitor (MAOI).
• Diphenhydramine inhibits CYP2D6 that partly responsible for the metabolism of some beta blokers including Metoprolol and the antidepressant Venlafaxine.

Pregnancy & lactation

Not to be used for neither pregnant nor nursing mothers.

Precautions & warnings

• Alcohol consumers. (with alcohol acetaminophen may cause liver damage).
• Alcohol, sedatives and tranquilizers may increase drowsiness.
• Be careful when driving a motor vehicle or operating machinery.
• Taking more than the recommended dose (overdose) may cause liver damage.

Ask a doctor before use if you have:

• Glaucoma.
• Trouble urinating due to an enlarged prostate gland.
• A breathing problem such as emphysema or chronic bronchitis.

Storage and Package

• Storage temperature should not exceed 30°C in a dry place.
• Carton box contains one or two strips. (AL/PVC) each one contains 10 film coated tablets and inner leaflet.
• Manufactured by: Egyptian Group For Pharmaceutical Industries (EGPI)- Egypt.

Cold Control – Information Leaflet

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