NITE TIME COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]

NITE TIME COLD MEDICINE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]
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NDC 53807-521-06
Set ID afb89586-4533-411b-95f5-3582418c6cf5
Category HUMAN OTC DRUG LABEL
Packager Rij Pharmaceutical Corporation
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 15 mL tablespoon)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr, 15 mgCough suppressant
    Doxylamine succinate 6.25 mgAntihistamine
  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches & 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

    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.
    • to make a child sleep
    • if you are allergic to acetaminophen or any of the ingredients in this product.

    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 enlarged prostate gland
    • a sodium-restricted diet

    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 use more than directed
    • 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.

    Overdose warning

    Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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

    • take only as recommended - see Overdose warning
    • use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hrs
    Adults and children 12 years and over2 TBSP (30 ml) every 6 hrs
    Children 4 to 12 yearsAsk a doctor
    Children under 4 yearsDo not use
  • Other information

    store at room temperature 15º - 30ºC (59º - 86ºF)
    protect from freezing.
    each tablespoon (15 mL) contains: sodium 46 mg
    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
  • Inactive ingredients

    alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD& C Yellow No. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, saccharin sodium, sodium citrate, sodium benzoate, water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    NITE TIME  COLD MEDICINE
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-521
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg  in 15 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 15 mL
    Doxylamine succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine succinate6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Green No. 3 (UNII: 3P3ONR6O1S)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-521-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-521)

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