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Major Night Time Multi Symptom (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5764-44) Label Information
CAPSULE, LIQUID FILLED 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0904-5764-12) Label Information

Complete Major Night Time Multi Symptom Information

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg


  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine


  • Uses

    • temporarily relieves common cold and flu symptoms:
      • sore throat
      • headache
      • minor aches and pains
      • fever
      • runny nose and sneezing
      • cough due to minor throat and bronchial irritation

  • 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

    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
    • to make a child sleep
    • 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.

    Ask a doctor before use if you have
    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis 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
    • 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
    • pain or cough 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 can 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 take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 6 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Day Time or Night Time products, carefully read each label to ensure correct dosing

  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • avoid excessive heat

  • Inactive ingredients

    D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol


  • Questions or comments?

     1-800-616-2471


  • Principal Display Panel

    Night Time

    MULTI-SYMPTOM COLD/FLU RELIEF

    ACETAMINOPHEN - Aches/Fever/Sore Throat

    Dextromethorphan HBr - Cough

    Doxylamine Succinate - Runny Nose/Sneezing

    Softgels

    †Compare to the active ingredients in Vicks® NyQuil® LiquiCaps®

    †This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil® LiquiCaps®.

    Distributed by:

    MAJOR® PHARAMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150, U.S.A.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


  • Product Label

    Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine succinate 6.25 mg

    Major Night Time Cold/Flu Relief Softgel


  • INGREDIENTS AND APPEARANCE
    MAJOR NIGHT TIME MULTI SYMPTOM  COLD AND FLU RELIEF
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5764
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color GREEN Score no score
    Shape CAPSULE (OBLONG) Size 20mm
    Flavor Imprint Code P30;94A;35A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5764-12 12 in 1 BLISTER PACK
    2 NDC:0904-5764-44 16 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 03/01/2012
    Labeler - Major Pharmaceuticals (191427277)