ALLERGY AND COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) CAPSULE, GELATIN COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]

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  • ALLERGY AND COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) CAPSULE, GELATIN COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]

ALLERGY AND COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) CAPSULE, GELATIN COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]
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NDC 59779-583-08
Set ID f09755f7-667b-4441-a6d6-c7f709f286df
Category HUMAN OTC DRUG LABEL
Packager WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients

    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 or hay fever or other upper respiratory allergies:
      • sneezing
      • runny nose
      • itchy, watery eyes
      • headache
      • sore throat
      • nasal congestion
      • cough
      • minor aches and pains
      • itching of the nose or throat
    • temporarily reduces fever
  • Warnings

    Liver warning:

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

    more than 12 gelcaps in 24 hours, 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

    • 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.

    Ask a doctor before use if you have

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

    • 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
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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 7 days
    • 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 or symptoms.
  • Directions

    • do not use more than directed (see overdose warning)
    • adults and children 12 years and over
      • take 2 gelcaps every 4 hours
      • do not take more than 12 gelcaps in 24 hours
    • children under 12 years
      • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store between 20º to 25ºC (68º to 77ºF).  Avoid high humidity.
    • see end flap for expiration date and lot number
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, proplyene glycol, shellac glaze, stearic acid, titanium dioxide
  • Questions or comments?

    1-800-426-9391
  • Principal Display Panel

    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 Benadryl® Allergy Plus Cold

    NEW!

    ALLERGY & COLD

    WITH FEVER REDUCER

    ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

    Pain reliever/Fever reducer, Antihistamine/Cough suppressant,

    Nasal decongestant

    See New Warnings Information

    Relief of:

    ✓ Headache    

    ✓ Sneezing

    ✓ Sore throat & Fever

    ✓ Itchy, watery eyes

    ✓ Sinus congestion

    ✓ Runny nose

    ✓ Itchy Throat

    ✓ Cough

    24 GELCAPS

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

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Dive

    Woonsocket, RI 02895

    © 2010 CVS/pharmacy

    www.cvs.com

    1-800-shop-CVS

    50844   ORG110958308

    Allegery Plus
  • INGREDIENTS AND APPEARANCE
    ALLERGY AND COLD 
    acetaminophen, diphenhydramine hcl and phenylephrine hcl capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-583
    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
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (pink with grey band) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code L;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-583-081 in 1 CARTON
    124 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/10/2009
    Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)
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