Severe Nighttime Severe Daytime

CVS Pharmacy

CVS Pharmacy, Inc. Severe Nighttime Severe Daytime Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each 30 mL dose cup) - Nighttime
• Active ingredients (in each 15 mL tablespoon) - Daytime
• Purpose - Nighttime
• Purpose - Daytime
• Severe Nighttime Severe Daytime Uses - Nighttime
• Severe Nighttime Severe Daytime 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
• Severe Nighttime Severe Daytime Other information - Nighttime
• Severe Nighttime Severe Daytime Other information - Daytime
• Inactive ingredients - Nighttime
• Inactive ingredients - Daytime
• Principal Display Panel - Nighttime
• Principal Display Panel - Daytime

FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup) - Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Active ingredients (in each 15 mL tablespoon) - Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses - Nighttime

temporarily relieves common cold/flu symptoms:

• •headache
• •nasal congestion
• •sinus congestion and pressure
• •fever
• •sore throat
• •runny nose and sneezing
• •minor aches and pains
• •cough due to minor throat and bronchial irritation
• •cough to help you sleep
• •reduces swelling of nasal passages
• •promotes nasal and/or sinus drainage
• •temporarily restores freer breathing through the nose

Uses - Daytime

temporarily relieves common cold/flu symptoms:

• •headache
• •fever
• •nasal congestion
• •sinus congestion and pressure
• •sore throat
• •promotes nasal and/or sinus drainage
• •reduces swelling of nasal passages
• •temporarily restores freer breathing through the nose
• •cough due to minor throat and bronchial irritation
• •minor aches and pains
• •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

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 such as occurs with smoking, asthma, chronic bronchitis, 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

• •do not use more than directed
• •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

• •you get nervous, dizzy or sleepless
• •pain, nasal congestion, 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

• •you get nervous, dizzy or sleepless
• •pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• •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 (overdose) may cause liver damage. 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 Overdose warning
• •use dose cup
• •do not exceed 4 doses per 24 hrs

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

Directions - Daytime

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

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

Other information - Nighttime

• •each 30 mL dose cup contains: sodium 12 mg

Other information - Daytime

• •each 15 mL tablespoon contains: sodium 6 mg

Inactive ingredients - Nighttime

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Inactive ingredients - Daytime

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

1-800-719-9260

Principal Display Panel - Nighttime

TWIN PACK!

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Compare to the active ingredients in Vicks® DayQuil® Severe and Vicks® NyQuil® Severe

SEVERE NIGHTTIME

MULTI-SYMPTOM COLD/FLU RELIEF

NASAL DECONGESTANT, PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

Maximum Strength Relief

Acetaminophen – aches, fever, sore throat

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

Phenylephrine HCl – nasal/sinus congestion & sinus pressure

Alcohol free

BERRY FLAVOR

TWO 12 FL OZ (355 mL) UNITS

Principal Display Panel - Daytime

TWIN PACK!

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

SEVERE DAYTIME

MULTI-SYMPTOM COLD/FLU RELIEF

NASAL DECONGESTANT, PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, EXPECTORANT

Maximum Strength Relief

Acetaminophen – aches, fever, sore throat

Dextromethorphan HBr – cough

Guaifenesin – chest congestion

Phenylephrine HCl – nasal congestion

Non-drowsy

Alcohol free

Antihistamine free

TOTAL 24 FL OZ (1.5 pt) (710 mL)