Good Sense NightTime DayTime Cold and Flu

L. Perrigo Company

Perrigo NightTime DayTime Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active ingredients (in each 15 mL tablespoon) - Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses - Nighttime

temporarily relieves common cold/flu symptoms:

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

Uses - Daytime

temporarily relieves common cold/flu symptoms:

• •cough due to minor throat and bronchial irritation
• •sore throat
• •headache
• •minor aches and pains
• •fever
• •nasal congestion

Warnings - Nighttime

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Warnings - Daytime

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. Severe liver damage may occur if

• •adult takes more than 4,000 mg of acetaminophen in 24 hours
• •child takes more than 5 doses in 24 hours, which is the maximum daily amount
• •taken with other drugs containing acetaminophen
• •adult has 3 or more alcoholic drinks every day while using this product

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, consult a doctor promptly.

Do not use - Nighttime

• •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 sleepy
• •if you have ever had an allergic reaction to this product or any of its ingredients

Do not use - Daytime

• •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.
• •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have - Nighttime

• •liver disease
• •trouble urinating due to an enlarged prostate gland
• •cough that occurs with too much phlegm (mucus)
• •persistent or chronic cough as occurs with smoking, asthma, or emphysema
• •a breathing problem such as emphysema or chronic bronchitis
• •glaucoma
• •a sodium-restricted diet

Ask a doctor before use if you have - Daytime

• •liver disease
• •high blood pressure
• •heart disease
• •thyroid disease
• •diabetes
• •trouble urinating due to an enlarged prostate gland
• •cough that occurs with too much phlegm (mucus)
• •persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are - Nighttime

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

Ask a doctor or pharmacist before use if you are - Daytime

taking the blood thinning drug warfarin

When using this product - Nighttime

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

When using this product - Daytime

do not use more than directed

Stop use and ask a doctor if - Nighttime

• •pain or cough 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.

Stop use and ask a doctor if - Daytime

• •pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• •you get nervous, dizzy or sleepless
• •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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions - Nighttime

• •take only as directed - see Liver warning
• •use dose cup
• •do not exceed 4 doses per 24 hrs

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

Directions - Daytime

• •take only as directed - see Liver warning
• •use dose cup
• •do not exceed 4 doses per 24 hrs

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

Other information - Nighttime

• •each 30 mL dose cup contains: sodium 38 mg
• •store at 20-25°C (68-77°F)

Other information - Daytime

• •each tablespoon contains: sodium 7 mg
• •store at 20-25°C (68-77°F)

Inactive ingredients - Nighttime

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Inactive ingredients - Daytime

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel - Nighttime

Multi-Symptom Relief

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

NightTime

Cold & Flu

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Aches

Fever

Cough

Sneezing

Runny Nose

Original Flavor

Compare to active ingredients of Vicks® NyQuil® Cold & Flu

12 FL OZ (354 mL)

ALCOHOL 10%

Package/Label Principal Display Panel - Daytime

Multi-Symptom Relief

Non-Drowsy

DayTime

Cold & Flu

Acetaminophen – Aches, Fever, Sore Throat

Dextromethorphan HBr – Cough

Phenylephrine HCl – Nasal Congestion

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

Compare to active ingredients of Vicks® DayQuil®

12 FL OZ (355 mL)

Alcohol Free

Antihistamine Free