ROBITUSSIN PEAK COLD NASAL RELIEF

Richmond Division of Wyeth

Robitussin Peak Cold Nasal Relief(acetaminophen, 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 do not use more than directed
  • 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

Phenylephrine HCl, USP 5 mg

PURPOSES

Pain reliever/Fever reducer

Nasal decongestant

USES

• temporarily relieves these symptoms associated with a cold or flu, hay fever or other upper respiratory allergies:
  • nasal congestion
  • sinus congestion and pressure
  • reduces swelling of nasal passages
  • restores freer breathing through the nose
  • headache
  • sore throat
  • minor aches and pains
• temporarily reduces fever

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

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for2 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

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

When using this product do not use more than directed

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, 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 Nasal Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

• Nasal Congestion
• Headache
• Sore Throat

Non-Drowsy

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