TOP VALUE EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD]

TOP VALUE EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD]
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NDC 50201-7682-2
Set ID 440a00b1-7960-0cc4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Tower Laboratories Ltd
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Purpose

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • Active ingredients

    Aspirin 325 mg (NSAID)*

    Chlorpheniramine maleate 2 mg

    Phenylephrine Bitartrate 7.8 mg

    *Nonsteroidal anti-inflammatory drug

  • Uses

    temporarily relieves these symptoms of the common cold

    ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache

    ■ minor aches and pains ■ runny nose

    ■ sinus congestion and pressure

  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

    ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

    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

    ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

    ■ if you are allergic to aspirin

    ■ 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

    ■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you are taking sedatives or tranquilizers

    You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

  • Ask a doctor or pharmacist before use if you are

    ■ presently taking a prescription drug.

    ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

  • When using this product

    ■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.

    ■ do not use more than directed

    ■ you may get drowsy

    ■ avoid alcoholic drinks

    ■ excitability may occur, especially in children

    ■ alcohol, sedatives and tranquilizers may increase drowsiness

    ■ be careful when driving a motor vehicle or operating machinery

  • Stop use and ask a doctor if

    ■ you experience any of the following signs of stomach bleeding

    ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better

    ■ an allergic reaction occurs. Seek medical help right away.

    ■ pain or nasal congestion gets worse or lasts more than 7 days

    ■ fever gets worse or lasts more than 3 days

    ■ new symptoms occur

    ■ redness or swelling is present

    ■ ringing in the ears or a loss of hearing occurs

    ■ nervousness, dizziness or sleeplessness occurs

  • If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • In case of overdose,

    get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    ■ do not use more than directed (see overdose warning)

    ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours

    ■ do not take more than 8 tablets in 24 hours

    ■ children under 12 years: ask a doctor

  • Other information

    each tablet contains:
    sodium 464 mg

    ■ phenylketonurics: contains phenylalanine 9 mg per tablet

    ■ store at room temperature (59°-86°F)

  • Inactive Ingredients:

    acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • QUESTIONS

    Serious side effects associated with the use of this product can be reported to the following address:

    Tower Laboratories LTD

    P.O. Box 306

    8 Industrial Park Road

    Centerbrook, CT 06409

  • PRINCIPAL DISPLAY PANEL

    Package label Principle display panel

  • INGREDIENTS AND APPEARANCE
    TOP VALUE EFFERVESCENT COLD RELIEF 
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50201-7682
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50201-7682-210 in 1 CARTON07/01/2010
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2010
    Labeler - Tower Laboratories Ltd (001587203)
    Registrant - Tower Laboratories Ltd (001587203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd869024500manufacture(50201-7682) , label(50201-7682) , pack(50201-7682)

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