NIGHT TIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]

NIGHT TIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-175-04
Set ID 3375a059-2939-438e-92b5-a7f1952bbb22
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Acetaminophen 325 mg 

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg 

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • cough to help you sleep
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • runny nose & sneezing
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • Warnings

    Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • 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 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • 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
    • taking the blood thinning drug warfarin

    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

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • 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 directed 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 directed - see Overdose warning
    • do not exceed 4 doses per 24 hrs

    adults & children 12 yrs and over

            2 softgels with water every 4 hrs

    children 4 to under 12 yrs

            ask a doctor

    children under 4 yrs         

            do not use

    • when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
  • Other information

    • store at room temperature and avoid excessive heat
  • 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

  • Questions or comments?

    Call toll free: 1-888-309-9030

  • PRINCIPAL DISPLAY PANEL - Carton Label

    Night Time Severe Cold & Flu Relief 24 Softgels

    Acetaminophen 325mg, Phenylephrine hydrochloride 5mg, Doxylamine succinate 6.25mg, Dextromethorphan hydrobromide 10mg

    NDC 51013-175-04

    *Compare to the active ingredients in Vicks® NyQuil® Severe Cold and Flu

    Carton Label

  • INGREDIENTS AND APPEARANCE
    NIGHT TIME SEVERE COLD AND FLU RELIEF 
    acetaminophen, phenylephrine hydrochloride, doxylamine succinate, dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-175
    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 HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorgreen (clear) Scoreno score
    Shapecapsule (oblong) Size20mm
    FlavorImprint Code PC22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-175-042 in 1 CARTON06/09/2016
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/09/2016
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-175) , analysis(51013-175)

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