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DAYTIME NIGHTTIME COLD and FLU


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each Softgel) (Daytime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 10mgCough suppressant
Phenylephrine HCl 5mgNasal Decongestant
Active ingredients (in each Softgel) (Nighttime)Purpose
Acetaminophen 325mgPain Reliever/fever reducer
Dextromethorphan HBr 15mgCough suppressant
Docylamine Succinate 6.25mgAntihistamine

OTC - PURPOSE SECTION

Daytime

Pain reliever/fever reducer, Cough suppresant and Nasal decongestant

Nighttime

Pain reliever/fever reducer, Cough suppressant and Antihistamine


INDICATIONS & USAGE SECTION

* temporarily relieves common cold/flu symptoms:

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

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: *more than 4 doses in 24 hrs, which is the maximum daily amount for this product * 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 *rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

if sore throat is severe, persists for 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 (Nighttime only).

Ask a doctor before use if you have

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

Ask a doctor or a pharmacist before use if you are * taking the blood thinning drug warfarin * taking sedatives or tranquilizers (Nighttime only) When using this productDo not use more than directed. In addition when using Nighttime: * excitability may occur, especially in children * marked drowsiness may occur * alcohol, sedatives, and tranquilizers may increase drowsiness * be careful when driving a motor vehicle or operating machinery * avoid alcoholic drinks

Stop use and ask a doctor if * you get nervous, dizzy, or sleepless (Daytime only) * pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days * new symptoms occur * fever gets worse or lasts more than 3 days * redness or swelling is present * 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 care professional before use. 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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.


DOSAGE & ADMINISTRATION SECTION

Directions * take only as directed - see OVERDOSE WARNING

* do not exceed 4 doses per 24 hrs * take softgels with water

Read each label carefully before taking Daytime and Nighttime product

DaytimeNighttime
adulta & children age 12 years & over2 softgels every 4 hours2 softgels every 6 hours
children 4 to under 12 yearsask a doctorask a doctor
children under 4 yearsdo not usedo not use

OTHER SAFETY INFORMATION

Other information * store at room temperature between 20 - 25°C (68 - 77°F)

*avoid excessive heat, cold and humidity


INACTIVE INGREDIENT SECTION

Inactive ingredients (Daytime) FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Inactive ingredients (Nightime) D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL