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 mg Dextromethorphan HBr 30 mgDoxylamine 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 andsneezing • 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 a skin 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 ornonprescription). If you are not sure whether a drug contains acetaminophen,ask a doctor or pharmacist • if you are now taking a prescription monoamineoxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping the MAOIdrug. If you do not know if your prescription drug contains an MAOI, ask adoctor 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 muchphlegm (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 sedativesor 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.
Keep out of reach of children.
Keep out of reach of children.
OVERDOSAGE SECTION
Overdose warning: Taking more than the recommended dose cancause serious health problems. In case of overdose, get medical helpor contact a Poison Control Center right away. Quick medical attentionis critical for adults as well as for children even if you do not noticeany signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions• take only as recommended-see Overdosewarning • Use dose cup or tablespoon ([BSP) • do not exceed4 doses per 24 hours • If taking Night Time at night and DayTime during the day, limit total to 4 doses per 24 hours.
adults & children 12 30 mL (2 TBSP)years and over every 6 hours
children 4 to ask a doctorunder 12 years
children under 4 years do not use
OTHER SAFETY INFORMATION
Other information • each 30 mL dose cupcontains: sodium 45 mg • store at room temperature
INACTIVE INGREDIENT SECTION
Inactive ingredientscitric acid, FD&C Blue No.1,FD&C Red No. 40, flavor, glycerin, polyethylene glycol,propylene glycol, purified water, saccharin sodium sodiumbenzoate, sodium citrate, sucrose
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30 am to 4:30 pm EST.1·877-798-5944.