Label: NIGHT COLD FLU COUGH AND ALLERGY- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled

  • NDC Code(s): 53345-020-01
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • Active ingredients (in each capsule)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine Succinate 6.25 mg

    Phenylephrine Hydrochloride 5 mg

  • Purpose

    Pain reliever/ fever reducer

    Cough suppressant 

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • nasal and sinus congestion
      • cough
      • sore throat
      • runny nose
      • sneezing
    • temporarily reduces fever
  • Warnings

    Liver warning

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

    • more than 10 softgels in 24 hours, 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.

    Do not use to sedate children.

    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
    •  in children under 12 years of age

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, 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 exceed recommended dosage
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs                                                                                   

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

    Keep out of reach of children.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

    • do not take more than the recommended dose
    • adults and children 12 years of age and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years of age: do not use
  • Other information

    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • Inactive ingredients

    FD&C blue #1, D&C yellow #10, 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 : 53345-020-01

    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"

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    NIGHT COLD FLU COUGH AND ALLERGY 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-020
    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) PHENYLEPHRINE HYDROCHLORIDE5 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) Size21mm
    FlavorImprint Code PC22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-020-011 in 1 BOX05/29/2013
    14000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/29/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287manufacture(53345-020)
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