Label: NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan, doxylamine succinate liquid
NIGHTTIME COLD AND FLU LIQUID CHERRY- acetaminophen, dextromethorphan, doxylamine succinate liquid

  • NDC Code(s): 81660-555-01, 81660-777-01
  • Packager: Grimann, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DOSAGE & ADMINISTRATION

    take only as directed

    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • WARNINGS

    Warnings

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

    more than 4 doses in 24 hrs, 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 skin reaction occurs, stop use and seek medical help right away

    Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • INACTIVE INGREDIENT

    Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose

  • INDICATIONS & USAGE

    Directions

    take only as directed
    only use the dose cup provided
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

  • KEEP OUT OF REACH OF CHILDREN

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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

  • PURPOSE

    Uses

    temporarily relieves common cold/flu symptoms:

    cough due to minor throat & bronchial irritation
    sore throat
    headache
    minor aches & pains
    fever

    runny nose and sneezing

  • ACTIVE INGREDIENT

    Active Ingredients (in each 30 mL) Purpose

    Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer

    Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant

    Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81660-777
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
    ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
    SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81660-777-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/11/2023
    NIGHTTIME COLD AND FLU LIQUID CHERRY 
    acetaminophen, dextromethorphan, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81660-555
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
    ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
    SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81660-555-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/11/2023
    Labeler - Grimann, S.A. de C.V. (812806982)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grimann, S.A. de C.V.812806982manufacture(81660-777, 81660-555) , label(81660-777, 81660-555)