Severe Cold Relief PE

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-526

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Severe Cold Relief PE Uses
• Warnings
  • Do not use
  • Ask a doctor before use if the user has
  • Ask a doctor or pharmacist before use if the user is
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Severe Cold Relief PE Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant

Severe Cold Relief PE Uses

• temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • cough
  • sore throat
• temporarily reduces fever 

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

• adults take more than 12 caplets in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks ever day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, naussea, or vomitting, 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
• with any other product containing diphenhydramine, even one used on skin
• 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 the user has

•  liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a cough accompanied by too much phlegm (mucus)

Ask a doctor or pharmacist before use if the user is

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

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

•  nervousness, dizziness, or sleeplessness occur
• pain, cough or nasal congestion gets worse or lasts more than 5 days (children) 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

• do not use more than directed (see overdose warning)

Severe Cold Relief PE Other information

• see end flap for expiration date and lot number
• store at controlled room temperature 15º-30ºC (59º-86ºF) 

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

Principal Display Panel

CVS®
pharmacy

Compare to the active ingredients in Sudafed PE® Severe Cold*

SEVERE
COLD RELIEF PE
MULTI-SYMPTOM
ACETAMINOPHEN
DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

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

• Nasal & Sinus Congestion    
• Fever & Body Aches
• Cough & Sore Throat

Does not contain Pseudoephedrine

12 COATED TABLETS 

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Severe Cold.

50844    REV0910C52602

Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2011 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING