NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]

NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.]
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NDC 57243-501-25
Set ID fcd24753-b42b-4d05-8379-0ec0351ab217
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART343
  • Drug FactsActive ingredients (in each 30 mL dose cup)


    Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  

  • Purpose


    Pain reliever/fever reducer  

    Cough suppressant  

    Antihistamine  

  • Keep Out Of Reach Of Children

    Keep out of reach of children.

  • Uses

     temporarily relieves cold/flu symptoms:

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

    Failure to follow these warnings could result in serious consequences

    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 amoun
      • 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 ccurs, 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.

  • Ask a doctor before use if you have

    • a sodium restricted diet
    • 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
  • Ask A Doctor or Pharmacist before use

    • if you are taking sedatives or tranquilizers
    • if you are taking the blood thinning drug warfarin
  • When Using This Product

    • do not use more than directed
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • Stop Use And Ask A Doctor If

    • redness or swelling is present
    • symptoms do not get better within 7 days or are accompanied by a fever
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts
  • Pregnant Or Breast-Feeding

    ask a health professional before use.

  • 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. Quick 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 warnings
    • Use dose cup or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
    • If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
    AptaPharma NiteTime2 Label

  • Other Information

    • each 30 mL dose cup contains:
    • sodium 45 mg
    • store at room temperature
  • Inactive ingredients

    citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

  • 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 sleepy
  • Product Label

    Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS

    Nite-Time COLD/FLU Medicine

    Multi-Symptom ORIGINAL FLAVOR

    Acetaminophen ..........................Aches, Fever and Sore Throat

    Dextromethorphan ......................Cough

    Doxylamine Succinate ................Sneezing, Runny nose

    6 FL OZ (177 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN


    *This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-002

    Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944

    Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com

    LOT:        EXP:

    Peel Here  DRUG FACTS CONTINUED ON BACK

    ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

    •  Antihistamine
    • Cough Suppressant
    • Pain Reliever
    • Fever Reducer

    AptaPharma Night-Time Label

  • INGREDIENTS AND APPEARANCE
    NITE-TIME  COLD/FLU ORIGINAL
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-501
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-501-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/16/2012
    Labeler - Salado Sales, Inc. (009830555)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(57243-501)

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