NITETIME COUGH LIQUID [KINGSTON PHARMA LLC]

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NITETIME COUGH LIQUID [KINGSTON PHARMA LLC]
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NDC 71027-041-06
Set ID de9c6c1d-ff69-49c2-8c18-2a556d229836
Category HUMAN OTC DRUG LABEL
Packager KINGSTON PHARMA LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Active Ingredient (in each 15 mL = 1 tablespoon):
    Acetaminophen 325 mg
    Dextromethorphan HBr 15 mg
    Doxylamine Succinate 6.25 mg

  • PURPOSE

    Purpose:
    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • Temporarily relieves these common cold/flu symptoms
      1. Cough due to minor throat and bronchial irritation
      2. Runny nose and sneezing
      3. Minor aches and pains
      4. Headache
      5. Sore throat
      6. Fever
  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

    • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
    • With other drugs containing acetaminophen.
    • Adult has 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.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

    Ask a doctor before use if you have

    • Glaucoma
    • Liver disease
    • Heart disease
    • High blood pressure
    • Thyroid disease
    • Diabetes
    • Trouble urinating due to an enlarged prostate gland
    • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • Cough that occurs with too much phlegm (mucus)
    • 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

    When using this product

    • Do not exceed recommended dosage
    • Excitability may occur especially in children
    • Marked drowsiness may occur
    • Avoid alcoholic drinks
    • Alcohol, sedatives and tranquilizers may increase drowsiness
    • Be careful when driving a motor vehicle or operating machinery

    Stop use and ask doctor if

    • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

    These could be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Do not take more than directed.
    • Use enclosed dosing cup.
    • Do not take more than 4 doses in 24-hours.
    • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 6 hours.
    • Children 4 to under 12 years: ask a doctor
    • Children under 4 years: do not use
    • When using other Daytime or Nite time products, carefully read each label to insure correct dosing
  • STORAGE AND HANDLING

    Other information

    • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
    • Each tablespoon contains: Sodium 46mg
  • INACTIVE INGREDIENT

    Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.

  • HOW SUPPLIED

    (packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

    Manufactured by: Kingston Pharma LLC
    5 County Route 42
    Massena, NY 13662

  • PRINCIPAL DISPLAY PANEL

    Label
    Label 2
  • INGREDIENTS AND APPEARANCE
    NITETIME COUGH 
    nitetime cough liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71027-041
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71027-041-061 in 1 CARTON03/01/2017
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2017
    Labeler - KINGSTON PHARMA LLC (080386521)
    Registrant - KINGSTON PHARMA LLC (080386521)
    Establishment
    NameAddressID/FEIBusiness Operations
    KINGSTON PHARMA LLC080386521manufacture(71027-041)
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