QUALITY CHOICE EFFERVESCENT COLD RELIEF PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [CHAIN DRUG MARKETING ASSOCIATION]

QUALITY CHOICE EFFERVESCENT COLD RELIEF PLUS (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-228-20
Set ID 90622927-9682-4eb0-8c7f-894230b3dda4
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

    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

  • PURPOSE

    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

    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. (See note below)

    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

    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 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 ■ 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 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

  • 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 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

    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

  • 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.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ do not use more than directed 

    ■ 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, flavors, mannitol, povidone, sodium

    benzoate, sodium bicarbonate

  • INDICATIONS & USAGE

    Fast Relief of: Nasal Congestion, Runny Nose, Sneezing, Headache, Sinus Pain & Pressure

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE EFFERVESCENT COLD RELIEF PLUS 
    aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-228
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMONImprint Code CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-228-2020 in 1 CARTON; Type 0: Not a Combination Product02/05/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2014
    Labeler - Chain Drug Marketing Association (011920774)