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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 25, 2023

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 finalpart34104/24/2023
    Labeler - Advanced Rx LLC (042795108)