Label: EFFERVESCENT COLD RELIEF- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 31, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients (in each effervescent tablet)                              Purpose

    Aspirin 325 mg NSAID*..........................................                 Pain reliever/fever reducer
    Chlorpheniramine maleate 2 mg ...............................                 Antihistamine
    Phenylephrine Bitartrate 7.8 mg ...............................                 Nasal decongestant

    *Nonsteroidal anti-inflammatory drug

  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers should not use this drug for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

    Allergy alert: Aspirin may cause a server 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.

  • ASK DOCTOR

    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 - glaucome - diabetes - thyroid disease - trouble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis - you are taking a diuretic - been placed on a sodium-restricted diet.

  • ASK DOCTOR/PHARMACIST

    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.

  • DO NOT USE

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    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.

  • PURPOSE

    Fast Relief of: Nasal Congetion, Runny Nose, Sneezing, Headache, Sinus Pain and Pressure

  • INDICATIONS & USAGE

    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

  • STOP USE

    Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint - vomit blood - have bloody 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 loss of hearing occurs - nervousness, dizziness or sleeplessness occurs.

  • WHEN USING

    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 a 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

  • ADVERSE REACTIONS

     Adverse Event Reporting: Serious side effects associated with the use of this product can be reported to the following address or by calling the following telephone number.

  • DOSAGE & ADMINISTRATION


    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

  • INACTIVE INGREDIENT


    Inactive ingredients:

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

  • PRINCIPAL DISPLAY PANEL

     image of carton

  • INGREDIENTS AND APPEARANCE
    EFFERVESCENT COLD RELIEF  
    aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50201-0246
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMON (N&A Lemon Lime Flavor FAKP193) Imprint Code CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50201-0246-12 in 1 POUCH
    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 (869024500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd869024500manufacture(50201-0246)