Label: COUGH AND COLD PLUS- acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr capsule, liquid filled

  • NDC Code(s): 53345-045-01
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine hydrochloride 5 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • Uses

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

    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.

    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 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: do not use
  • Other information

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

    Butylated Hydroxyanisole (BHA), D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink 

  • Questions or commonts

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Cough and Cold plus Capsules

    Each softgel contains: Acetaminophen 325 mg Phenylephrine HCl 5 mg

    Chlorpheniramine Maleate 2 mg Dextromethorphan HBr 10 mg

    Quantity: 4000 Capsules

    NDC No.:53345-045-01

    MADE IN CHINA

    IMPORTANT:

    1. Inspect immediately upon receipt.
    2. This is a bulk shipment, intended for further processing only.
    3. Protect from heat, humidity, and light. Do not refrigerate.
    4. 4.Store at 15-30°C (59-86)°F

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD PLUS 
    acetaminophen, phenylephrine hcl, chlorpheniramine maleate, dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorpurple (Clear) Scoreno score
    ShapeCAPSULE (Oblong) Size21mm
    FlavorImprint Code P18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-045-011 in 1 BOX03/24/2017
    14000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/24/2017
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(53345-045)
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