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Severe Cold Relief PE by WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Diphenhydramine Hydrochloride 12.5mg, Phenylephrine Hydrochloride 5mg
Labeler: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC Code: 59779-526

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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:

  • adult takes more than 12 caplets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taking 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, condult 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 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)
  • a persistant or chronic cough such as occurs with smoking, asthma, or emphysema
  • a breathing problem such as emphysema or chronic bronchitis

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) 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 Centrer right away. Quick 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 directed (see overdose warning)
adults and children 12 years and over

take 2 caplets every 4 hours

do not take more than 12 caplets in 24 hours

children 6 to under 12 years of age

take one caplet every 4 hours

do not take more than 5 caplets in 24 hours

children under 6 years of agedo not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  • see end flap for expiration date and lot number
  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

1-800-426-9391

PRODUCT PACKAGING

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

CVS®

pharmacy

Compare to the active ingredients in

Sudafed PE® Severe Cold*

See New Warnings Information

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

24 COATED CAPLETS

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

50844           REV1209B52608

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com

1-800-shop-CVS

SEVERE COLD RELIEF PE  
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-526
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride12.5 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
Starch, Corn 
Croscarmellose Sodium 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polyethylene Glycol 
Polyvinyl Alcohol 
Povidone 
Silicon Dioxide 
Stearic Acid 
Talc 
Titanium Dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code44;526
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-526-021 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:59779-526-081 BLISTER PACK (BLISTER PACK) in 1 CARTON
224 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/21/2005
Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIOperations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 08/2010
 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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