TheraFlu Severe Cold Caplets (Novartis Consumer)

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Drug Facts

Active Ingredients:

(in each caplet)    Purpose:

Acetaminophen

   500 mg     Pain reliever/

Fever reducer

Chlorpheniramine maleate

   2 mg      Antihistamine

Dextromethorphan HBr

   15 mg     Cough suppressant

Pseudoephedrine HCl

   30 mg     Nasal decongestant

Uses:    temporarily relieves:

· headache · minor aches and pains · runny nose · sneezing · itchy nose or throat · itchy, watery eyes due to hay fever · minor sore throat pain · nasal and sinus congestion · cough due to minor throat and bronchial irritation

· temporarily reduces fever

Warnings:

Alcohol Warning:    If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or any other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use · if you are now taking a prescription monamine oxidase inhibitor (MAOI) (certain drugs for depression), psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

· with any other product containing acetaminophen (see Overdose Warning )

Ask a doctor before use if you have · heart disease · high blood pressure · thyroid disease · diabetes · glaucoma · a breathing problem such as emphysema, asthma, or chronic bronchitis

· trouble urinating due to an enlarged prostate gland

· cough that occurs with smoking, too much phlegm (mucus) or chronic cough that lasts

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product · do not take more than directed · avoid alcoholic drinks

• may cause marked drowsiness
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if · nervousness, dizziness, or sleeplessness occurs

• pain, cough or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

Overdose Warning:    Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

• do not use more than directed (see Overdose Warning )
• take every 6 hours; not more than 8 caplets in 24 hours
• adults and children 12 years of age and over: 2 caplets every 6 hours
• children under 12 years of age: consult a doctor

Other Information:   · each caplet contains: sodium 6 mg · store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients:    colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10 aluminum lake, FD&C Blue 1 aluminum lake, FD&C Yellow 6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, triacetin

How Supplied:    24 coated caplets

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