NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]

NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]
PDF | XML

NDC 53345-006-01
Set ID a01abac3-c13e-40f2-ae98-34bd6c9b7504
Category HUMAN OTC DRUG LABEL
Packager Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 15 mg

    Doxylamine Succinate 6.25 mg

  • Purpose

    Pain reliever/ fever reducer

    Cough suppressant 

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches/pains
    • fever
    • runny nose & 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
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • DO NOT USE

    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                                                                                                         
  • Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • cough with excessive phlegm(mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • difficulty in urinating due to an enlarged prostate gland

  • 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 exceed the recommended dosage
    • do not use for more than 7 days
    • 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

    Stop use and Ask a doctor if

    • you get nervous, dizzy, or sleepless
    • swelling or redness is present
    • symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
    • cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.

    These may be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) could 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 children even if you do not notice any signs or symptoms.

  • Directions

    • take only as directed - see overdose warning
    • do not exceed 4 doses per 24 hours

    Adults and children 12 years of age and over

     Swallow 2 softgels with water every 6 hours

    Children 4 to 12 years of age

     ask a doctor

    children under4 years o9f age

    do not use

    If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.

  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
    • this product does not contain phenylpropanolamine (PPA)
  • Inactive ingredients

    D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
    Wuhan, Hubei
    430206, China

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    NIGHTTIME COLD AND FLU CAPSULES

    Quantity : 4000 Capsules
    NDC. No : 53345-006-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

    NightTime Capsules Bulk Label

    PLD Label

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code PC10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-006-011 in 1 BOX04/15/2013
    14000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-006) , ANALYSIS(53345-006)

Related Drugs