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NIGHTTIME SEVERE COLD AND FLU


Drug Facts


Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg


Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

Warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 softgels in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


OTC - DO NOT USE SECTION

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. • if you are now taking a prescription monoamine 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.


OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland


OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are• taking sedatives or tranquilizers • taking the blood thinning drug warfarin


OTC - WHEN USING SECTION

When using this product• do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur n avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness


OTC - STOP USE SECTION

Stop use and ask a doctor if• you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days n redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.


OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions

adults & children 12 years & over2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
  • take only as directed
  • ndo not exceed 8 softgels per 24 hour

Other information

• do not exceed 25°C (77°F)


Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, sodium hydroxide*, titanium dioxide * may contain this ingredient


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

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