Cold & Flu Night-time Multi-Symptom Relief

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL dose cup)Acetaminophen                650 mgDextromethorphan HBr      30mg Doxylamine Succinate     12.5 mg

OTC - PURPOSE SECTION

PurposeAcetaminophen                 Pain reliever/fever reducerDextromethorphan HBr     Cough suppressantDoxylamine Succinate       Antihistamine

INDICATIONS & USAGE SECTION

Uses temporarily relieves cold/flu symptoms: • sore throat • headache• minor aches and pain • fever • runny nose and sneezing• cough due to minor throat and bronchial irritation

WARNINGS SECTION

WarningsLiver warning: This product contains acetaminophen. Severe liverdamage may occur if you take• more than 4,000 mg of Acetaminophen 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.

Allergy alert: Acetaminophen may cause severe skin reactions.Symptoms may include: • skin reddening • blisters • rashIf askin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more thantwo 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 drugcontains acetaminophen, ask a doctor or pharmacist• if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product.• to make a child sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have• a sodium restricted diet • liver disease • glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem or chronic cough that lasts or as occurs withsmoking, 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• if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product • do not use more than directed• avoid alcoholic drinks • excitability may occur, especially in children• marked drowsiness may occur• 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 • redness or swelling is present• symptoms do not get better within 7 days or are accompanied by a fever• fever gets worse or lasts more than 3 days • new symptoms occur• cough lasts more than 7 days, comes back, or occurs with fever, 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.

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose can causeserious health problems. In case of overdose, get medical help or contact aPoison Control Center right away. Quick medical attention is critical for adultsas well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions • take only as recommended-see Overdose warning• Use dose cup or tablespoon (TBSP)• do not exceed 4 doses per 24 hours

adults and children 12              30 mL (2 TBSP)years and over                         every 6 hours

children 4 to                             ask a doctorunder 12 years                     

children under 4years              do not use

• If taking Night Time at night and Day Time during the day,limit total to 4 doses per 24 hours.

OTHER SAFETY INFORMATION

Other information • each 30 mL dose cup contains:sodium 45 mg • store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients citric acid, D&C yellow # 10, FD&CGreen No.3, FD&C Yellow No.6, flavor, glycerin,polyethylene glycol, propylene glycol, purified water,saccharin sodium, sodium benzoate, sodium citrate, sucrose

OTC - QUESTIONS SECTION

QuestIons? Call weekdays from 9:30 am to 4:30 pm EST.1-877-798-5944.