PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]

PAIN RELIEVER FEVER REDUCER (ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE,PHENYLEPHRINE HYDROCHLORIDE,CHLORPHENIRAMINE MALEATE) TABLET, EFFERVESCENT [VELOCITY PHARMA]
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NDC 76168-021-13
Set ID 8600db56-a877-4557-ab71-d46b72d642c9
Category HUMAN OTC DRUG LABEL
Packager Velocity Pharma
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active Ingredient

    (in each tablet)

    Acetaminophen 250 mg

    Chlorpheniramine Maleate 2mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

  • Purpose

    pain reliever/fever reducer

    Antihistamine

    Cough Suppressant

    Nasal decongestant

  • Uses

    Temporarily relieves these symptoms due to cold or flu:

    • Minor aches and pains
    • Headaches
    • Cough
    • Sore throat
    • Runny nose
    • Sneezing
    • Nasal and sinus congestion
    • Temporarily reduces fever
  • Warnings

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

    • more than 8 tablets in 24 hours which is maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat waring: If sore throat is sever, 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 not prescription). 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.

    Ask a doctor before use if you have

    • liver disease
    • Heart disease
    • Thyroid disease
    • Diabetes
    • High blood pressure
    • Glaucoma
    • Cough with excessive phlegm (mucus)
    • A breathing problem such as emphysema or chronic bronchitis
    • Difficulty in urinating due to enlargement of prostate gland
    • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • A sodium restricted diet

    ask your doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin.
    • taking sedative or tranquilizers

    when using this product

    • do not exceed recommended dosage
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedative 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 serious condition.
    • Nervousness, dizziness, or sleeplessness occurs
    • If pregnant or breast-feeding, ask a health professional before use
  • Keep out of reach of children.

    Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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 for children even if you do not notice any signs or symptoms.

  • Direction

    • do not take more than the recommended dose
    • Adults and children 12 years and over: 2 tablets fully dissolved in 4 oz of water every 4 hours, Do not exceed 8 tablets in 24 hours or as directed by a doctor
    • children under 12 years: do not use
  • Other Information

    • phenylketonurics: contains phenylalanine 15 mg per tablet
    • store at room temperature  , avoid excessive heat.

    Total sodium : 415 mg/tablet

    Total potassium: 1mg /tablet

  • INACTIVE INGREDIENT

    acesulfame potassium, aspartame, citric acid anhydrous, color ponceau 4r, isopropyl alcohol, mannitol, orange flavor, pvp k-30, Simethicone, sodium benzoate, sodium bicarbonate, sodium saccharin, tween 80.

  • QUESTIONS

    Call toll free 1-855-314-1850

    Distributed by Velocity Pharma Llc

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    240453b0-figure-01

    NDC: 76168-021-13   6 tablets

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER FEVER REDUCER 
    acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PONCEAU 4R (UNII: Z525CBK9PG)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANNITOL (UNII: 3OWL53L36A)  
    ORANGE (UNII: 5EVU04N5QU)  
    POVIDONE K30 (UNII: U725QWY32X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-021-136 in 1 BLISTER PACK
    11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/15/2014
    Labeler - Velocity Pharma (962198409)
    Registrant - Velocity Pharma (962198409)

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