MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [PROFICIENT RX LP]

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  • MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [PROFICIENT RX LP]

MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [PROFICIENT RX LP]
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NDC 63187-652-24
Set ID 9bf81b26-38b4-486c-ae89-222119ce1a4f
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant 

  • Uses

    •
    temporarily relieves these common cold/flu symptoms:
    •
    minor aches and pains
    •
    headache
    •
    nasal congestion
    •
    cough
    •
    sore throat
    •
    sinus congestion and pressure
    •
    helps clear nasal passages
    •
    promotes nasal and sinus drainage
    •
    temporarily reduces fever 
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of ths product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    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.
    •
    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 using this product. 

    Ask a doctor before use if you have

    •
    liver disease
    •
    diabetes
    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    trouble urinating due to an enlarged prostate gland
    •
    persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    •
    cough that occurs with too much phlegm (mucus) 

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    •
    nervousness, dizziness, or sleeplessness occur
    •
    pain, nasal congestion, or cough gets worse or lasts more than 7 days
    •
    new symptoms occur
    •
    fever gets worse or lasts more than 3 days
    •
    redness or swelling is present
    •
    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 (1-800-222-1222) 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 take more than directed (see overdose warning)
    •
    adults and children 12 years and over:
    •
    take 2 caplets every 4 hours
    •
    swallow whole - do not crush, chew, or dissolve
    •
    do not take more than 10 caplets in 24 hours
    •
    children under 12 years: ask a doctor
  • Other information

    •
    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86º)
    •
    see end flap for expiration date and lot number 
  • Inactive ingredients

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

  • Questions or comments?

    (800) 616-2471 

  • Principal Display Panel

    Major®

    NDC 63187-652-24

    MULTI-SYMPTOM
    Mapap®
    COLD FORMULA
    CAPLETS

    ASPIRIN FREE
    ACETAMINOPHEN
    DEXTROMETHORPHAN HBr
    PHENYLEPHRINE HCl

    DAYTIME • NON-DROWSY

    Pain Reliever / Fever Reducer
    Cough Suppressant • Nasal Decongestant

    For Relief of: Fever, Headache,
    Sore Throat, Nasal Congestion, Coughing

    24 CAPLETS with Cool Blast Flavor

    Compare to active ingredients in TYLENOL® Cold Multi-Symptom Daytime*

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Daytime.        50844            REV0213D47008

    Distributed by MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive
    Livonia, MI 48150 USA        M-17        Rev.02/13

    Relabeled by Proficient Rx LP

    Thousand Oaks, CA 91320

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

    63187-652-24

    Major 44-470C

  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM MAPAP COLD FORMULA 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-652(NDC:0904-5786)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorMINTImprint Code 44;470
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-652-242 in 1 CARTON02/01/2016
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/15/2005
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-652)
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