Label: NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 13, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (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:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
  • WARNINGS

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

    • more than 4 doses in 24 hours, which is the maximum daily amount for this product
    • 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:

    • skin reddening
    • blisters
    • rash

    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 products containing acetaminophen (prescription or non-prescription). 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

    • liver disease
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    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

    Keep out of reach of children. 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 and for children even if you do not notice any signs or symptoms.

  • DIRECTIONS

    • take only as directed
    • do not exceed 4 doses per 24 hours
    adults and children 12 years and overtake 2 softgels with water every 6 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use

  • OTHER INFORMATION

    • store at room temperature
  • INACTIVE INGREDIENTS

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

  • QUESTIONS?

    call toll-free 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    PDP

    DF1

    DF2

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU RELIEF SOFTGELS   MULTI-SYMPTOM
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code IS2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-302-5050 in 1 BOTTLE; Type 0: Not a Combination Product04/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/24/2023
    Labeler - Advanced Rx LLC (042795108)