NITE TIME COLD AND FLU

PuraVation Pharmaceuticals Inc

NITE TIME COLD AND FLU capsule, liquid filled

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each softgel)
• Purpose
• NITE TIME COLD AND FLU Uses
• Warnings
• Ask a doctor before use if you have
• Ask a doctor or pharmacist before use if you are
• When using this product
• Directions
• NITE TIME COLD AND FLU Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant 

Antihistamine

NITE TIME COLD AND FLU Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches/pains
• fever
• runny nose & sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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. 
• To make a child sleep                                                                                                         

Ask a doctor before use if you have

• liver disease
• heart disease
• asthma
• emphysema
• thyroid disease
• diabetes
• glaucoma
• high blood pressure
• cough with excessive phlegm(mucus)
• breathing problems
• chronic bronchitis
• persistent or chronic cough
• cough associated with smoking
• difficulty in urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not exceed the recommended dosage
• do not use with other products containing acetaminophen
• do not use for more than 7 days
• excitability may occur especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and Ask a doctor if

• you get nervous, dizzy, or sleepless
• swelling or redness is present
• symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
• cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.

These may be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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 children even if you do not notice any signs or symptoms.

Directions

• take only as recommended - see overdose warning
• do not exceed 4 doses per 24 hours

If taking NITE TIME and DAY TIME softgels carefully read each label to insure correct dosing.

NITE TIME COLD AND FLU Other information

• store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
• this product does not contain phenylpropanolamine (PPA)

Inactive ingredients

D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Questions or comments? Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

NITE TIME

LIQUID CAPS

ADULT NIGHTTIME COLD/FLU MEDICINE

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

PAIN RELIEVER, FEVER REDUCER, COUGHT SUPPRESSANT, ANTIHISTAMINE

Compare to the active ingredients in Vicks® NyQuil®