MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS]

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  • MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS]

MULTI-SYMPTOM MAPAP COLD FORMULA (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS]
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NDC 0904-5786-24
Set ID 97f548d8-df01-4650-88a4-7701ec2b9be2
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
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 and flu symptoms:
      • minor aches and pains
      • nasal congestion
      • headache
      • cough
      • sinus congestion and pressure
      • sore throat
    • helps clear nasal passages
    • promotes nasal and sinus drainage
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    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 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 you have

    • thyroid disease
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland
    • liver disease
    • heart disease
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • diabetes
    • 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    (800) 616-2471 

  • Principal Display Panel

    MAJOR®

    NDC 0904-5786-24
    Compare to active ingredients in Tylenol® COLD MAX*

    MULTI-SYMPTOM
    Mapap®
    COLD FORMULA
    CAPLETS

    ACETAMINOPHEN
    DEXTROMETHORPHAN HBr
    PHENYLEPHRINE HCl
    Pain Reliever / Fever Reducer
    Cough Suppressant • Nasal Decongestant

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

    DAYTIME • NON-DROWSY
    ASPIRIN FREE

    24 CAPLETS with Cool Blast Flavor

    Actual Size

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® COLD MAX.     
    50844            REV0718F47008

    Distributed by MAJOR® PHARMACEUTICALS
    17177 N Laurel Park Drive, Suite 233
    Livonia, MI 48152 USA        M-17        Rev. 08/18
    Re-order No. 006363

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

    Major 44-470C

    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: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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorMINTImprint Code 44;470
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5786-242 in 1 CARTON07/15/2005
    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 - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0904-5786)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-5786)
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