NITE TIME COLD FLU RELIEF (ACETAMINOPHEN,DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WE CARE DISTRIBUTOR INC.]

NITE TIME COLD FLU RELIEF (ACETAMINOPHEN,DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [WE CARE DISTRIBUTOR INC.]
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NDC 70005-046-01
Set ID 9ad5cc14-01f6-4315-bebf-267ef1c952eb
Category HUMAN OTC DRUG LABEL
Packager We Care Distributor Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredient (in each 15 mL tablespoon)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine succinate 6.25 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

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

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses. Severe liver damage may occur if adult/child takes:

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 two 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • to make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

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

    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

    • redness or swelling is present
    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • 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 recommended dose may 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 directed. (see overdose warning)
    • use dose cup
    • do not exceed 4 doses per 24 hours
    adults and children 12 years and over30 mL every 6 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other information

    • each 15 mL (tablespoon) contains: sodium 46 mg
    • store at 15°-30°C (59°-86°F)
    • protect from freezing
  • 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, purified water, saccharin sodium, sodium citrate, sodium benzoate

  • Questions or comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    See New Warnings Information

    Compare to NyQuil® Cold & Flu Active Ingredients

    NiteTime

    Cold & Flu

    Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

    Multi-Symptom Relief

    Aches, Fever - Acetaminophen

    Cough - Dextromethorphan HBr

    Sneezing, Runny Nose - Doxylamine Succinate

    Original Flavor

    10% Alcohol

    NiteTime Cold and Flu Label 1

    NiteTime Cold and Flu Label 2

  • INGREDIENTS AND APPEARANCE
    NITE TIME  COLD FLU RELIEF
    acetaminophen,dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-046
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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 GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorGREEN (Bright) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-046-011 in 1 CARTON08/10/2016
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/10/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINE PHARMA LLC019950491manufacture(70005-046)

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