Label: SEVERE COLD RELIEF PE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated August 26, 2010

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  • 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

    Product Label
  • INGREDIENTS AND APPEARANCE
    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 AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Starch, Corn (UNII: O8232NY3SJ)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Polyvinyl Alcohol (UNII: 532B59J990)  
    Povidone (UNII: FZ989GH94E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 44;526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-526-021 in 1 CARTON
    112 in 1 BLISTER PACK
    2NDC:59779-526-081 in 1 CARTON
    224 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/FEIBusiness Operations
    L.N.K. International, Inc832867894MANUFACTURE
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