Daytime Nighttime Cold/Flu

BJWC (Berkley & Jensen / BJ's)
P and L Development of New York Corporation

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients in Daytime (in each softgel)
• Active ingredients in Nighttime (in each softgel)
• Purpose for Daytime
• Purpose for Nighttime
• Daytime Nighttime Cold/Flu Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Daytime Nighttime Cold/Flu Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel
• Product Label

FULL PRESCRIBING INFORMATION

Active ingredients in Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Daytime Nighttime Cold/Flu Uses

temporarily relieves common cold and flu symptoms:

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

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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

Do not use

• to make a child sleep (Nighttime only)
• 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.

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis
• glaucoma (Nighttime only)
• diabetes (Daytime only)    
• heart disease (Daytime only)
• thyroid disease (Daytime only)
• high blood pressure (Daytime only)  

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Nighttime only)

When using this product

• do not exceed recommended dosage

In addition, when using Nighttime:

• excitability may occur, especially in children
• avoid alcoholic drinks  
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness 
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur (Daytime only)
• pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days  
• fever gets worse or lasts more than 3 days
• 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.

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 can cause liver damage. 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.

Directions

• do not take more than directed (see overdose warning)
• do not take more than 4 doses in 24 hours
• swallow whole: do not crush, chew, or dissolve
• Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
• Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours
• children under 12 years: do not use

Daytime Nighttime Cold/Flu Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat

Inactive ingredients

Inactive ingredients in Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol 

*may contain this ingredient

Inactive ingredients in Nighttime D&C Yellow #10, edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Berkley & Jenses

COLD & FLU

DAY & NIGHT

MULTI-SYMPTOM COLD/FLU RELIEF

Compare to Vicks® DayQuil® and Vicks® NyQuil® Liquicaps® active ingredients†

NON-DROWSY Acetaminophen - Aches/Fever/Sore Throat

Dextromethorphan Hydrobromide - Cough

Phenylephrine HCl - Nasal Congestion

Acetaminophen - Aches/Fever/Sore Thoat

Dextromethorphan HBr - Cough

Doxylamine Succinate - Runny Nose/Sneezing

DAYTIME SOFTGELS/ NIGHTTIME SOFTGELS

†This product are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and Vicks® NyQuil® Liquicaps®

Distributed by BJWC,

25 Research Drive, Westborough, MA  01581

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING..

Product Label