ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF

Richmond Division of Wyeth

Robitussin Peak Cold Nighttime Nasal Relief[acetaminophen, chlorpheniramine maleate, and phenylephrine HCl]

FULL PRESCRIBING INFORMATION: CONTENTS*

• DRUG FACTS
• ACTIVE INGREDIENTS (IN EACH TABLET)
• PURPOSES
• USES
• WARNINGS
  • Liver warning:
  • Sore throat warning:
  • 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
• OTHER INFORMATION
• INACTIVE INGREDIENTS
• QUESTIONS OR COMMENTS?
• PRODUCT PACKAGING

FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Acetaminophen, USP 325 mg

Chlorpheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

USES

• temporarily relieves these symptoms associated with a cold, or flu:
  • headache
  • nasal congestion
  • sore throat
  • fever
  • minor aches and pains
• temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • nasal congestion
  • itching of the nose or throat
  • itchy, watery eyes
• temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 tablets in any 24-hour period, which is the maximum daily amount
• 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 or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to sedate a child or to make a child sleepy
• 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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema, asthma, or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

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

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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DIRECTIONS

• do not use more than 12 tablets in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage
• this adult product is not intended for use in children under 12 years of age

OTHER INFORMATION

• store at 20-25°C (68-77°F)
• tamper-evident individual blisters

INACTIVE INGREDIENTS

calcium stearate, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NEW!

ADULT

Robitussin PEAK COLD NIGHTTIME Nasal Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

CHLORPHENIRAMINE MALEATE (Antihistamine)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

• Nasal Congestion
• Headache
• Sore Throat
• Runny Nose

For Ages 12 & Over

20 TABLETS

Tablets individually blister sealed. If seal is broken, Do Not Use.

For most recent product information, visit www.robitussin.com

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

Made in Canada