DAYTIME NIGHTTIME COLD/FLU RELIEF

A P J Laboratories Limited
A P J Laboratories Limited

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACTIVE INGREDIENT
• PURPOSE
• Keep out of reach of children
• USES
• WARNINGS
• DIRECTIONS
• INACTIVE INGREDIENT

FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

PART 1 OF 2 DAYTIME COLD AND FLU RELIEF

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Phenylephrine HCl 5 mg

PART 2 OF 2 NIGHTTIME COLD AND FLU RELIEF

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 10 mg

Chlorpheniramine Maleate 6.25 mg

PURPOSE

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Keep out of reach of children

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

USES

Temporarily relieves common cold/flu symptoms:

•cough due to minor throat and bronchial irritation
•sore throat
•headache
•minor aches and pains
•fever
•runny nose and sneezing (Nighttime only)
•nasal congestion (Daytime only)

WARNINGS

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

•more than 4 doses in 24 hours, which is the maximum daily amount for these products

•with other drugs containing acetaminophen

•3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 (Nighttime only)

DIRECTIONS

•take only as directed – see Overdose warning

•take Nighttime OR Daytime.

Nighttime tablets

•do not exceed 4 doses per 24 hours

 adults and children 12 years and over  swallow 2 softgels with water every 6 hrs

 children 4 to under 12 years  ask a doctor

 children under 4 years  do not use

DayTime tablets

•do not exceed 4 doses per 24 hours

 adults and children 12 years and over  swallow 2 softgels with water every 4 hrs

 children 4 to under 12 years  ask a doctor

 children under 4 years  do not use

•when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

INACTIVE INGREDIENT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

STARCH, CORN

BUTYLATED HYDROXYTOLUENE

METHYLPARABEN

PROPYLPARABEN

SODIUM STARCH GLYCOLATE TYPE A POTATO

TALC

MAGNESIUM STEARATE

SILICON DIOXIDE

CROSCARMELLOSE SODIUM

SODIUM LAURYL SULFATE

ISOPROPYL ALCOHOL

METHYLENE CHLORIDE

FD and C YELLOW NO. 6

HYPROMELLOSES