NIGHT TIME PSEUDO-FREE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]

NIGHT TIME PSEUDO-FREE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-113-06
Set ID e119fafe-9d50-4555-9bd9-389e4a1e2718
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active Ingredients

    Acetaminophen 500 mg
    Dextromethorphan HBr 15 mg
    Doxylamine succinate 6.25 mg

  • Purposes

    Acetaminophen...........................................Pain reliever/fever reducer
    Dextromethorphan HBr.....................................................Cough suppressant
    Doxylamine succinate...............................................................Antihistamine

  • Uses

    temporarily relieves these common cold/flu symptoms: • minor aches and pains
    • headache • muscular aches • sore throat • fever • runny nose and sneezing
    • itchy nose or throat • coughs • cough due to minor throat and bronchial irritation
    • itchy, watery eyes due to hay fever or other upper respiratory allergies

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur
    if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the
    maximum daily amount • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product
    Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high
    fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away.
    Do not use more than 2 days or give to children under 12 years of age unless directed
    by a doctor.

  • Do Not Use

    • to make a child sleepy • if you are on a sodium-restricted diet
    • 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 two
    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.
    • with any other drug containing acetaminophen (prescription or non-prescription).
    If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • Ask a doctor before use if you have

    • liver disease • glaucoma • breathing problems
    • chronic bronchitis • trouble urinating due to enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma or emphysema or if
    cough is accompanied by excessive phlegm (mucus)

  • Ask a doctor or pharmacist before use if you are taking

    • sedatives or tranquilizers • the blood thinning drug warfarin

  • When using this product

    • do not use more than directed (see overdose warning)
    • 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 • new symptoms occur
    • you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days
    • pain or cough gets worse or lasts more than 7 days
    • 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 this and all drugs out of the reach of children.

    Overdose Warning: Taking more than the recommended dose (overdose) could cause
    serious health problems, including liver damage. In case of accidental overdose, seek
    professional assistance or contact a Poison Control Center immediately. Quick medical
    attention is critical for adults as well as for children even if you do not notice any signs
    or symptoms.

  • Directions

    • use dosage cup or tablespoon (TBSP)
    • take only as recommended (see overdose warning)
    • do not exceed 4 doses per 24 hours

    age                                                                            dose
    adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours
    children 4 years to under 12 years.......................do not use unless directed by a doctor
    children under 4 years..........................................do not use

    • When using Day Time and Night Time products,
    carefully read each label to ensure correct dosing.

  • Other Information

    • store at controlled room temperature
    • sodium content per tablespoon: 18 mg

  • Inactive Ingredients

    alcohol, blue 1, citric acid, flavor,
    high fructose corn syrup, polyethylene glycol, propylene glycol,
    purified water, red 40, saccharin sodium, sodium citrate

  • Principal Display Panel

    Compare to the Active Ingredients in Vicks Nyquil
    Premier Value
    Cherry Night Time Multi Symptom Cold and Flu Relief
    Acetaminophen...Pain Reliever and fever reducer
    Dextromethorphan HBr....Cough suppressant
    Doxylamine Succinate......Antihistamine
    See new dosing and warning information
    10 percent alcohol
    Premier Value Guarantee
    6 fl oz 177mL

  • Package Label

     Acetaminophen 500 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg

    Premier Value Night Time

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME  PSEUDO-FREE
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Nyquil Type Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-113-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/13/2010
    Labeler - Chain Drug Consortium, LLC (101668460)

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