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REESES ONETAB ALLERGY AND SINUS (REESE PHARMACEUTICAL CO.)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (10956-812-01) > 30 TABLET in 1 BOTTLE, PLASTIC (10956-812-30) Label Information

Complete REESES ONETAB ALLERGY AND SINUS Information

  • ACTIVE INGREDIENT

    Acetaminophen 650 mg
    Diphenhydramine Hydochloride 25 mg
    Phenylephrine Hydrochloride 10 mg

    croscarmellose sodium,htpromellose,magnesium silicate,magnesium stearate,

    microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,

    stearic acid,titanium dioxide.

  • PURPOSE

    Pain Reliever/Fever Reducer

    Antihistamine/Cough Suppressant

    Nasal Decongestant


  • INDICATIONS & USAGE

    Temporarily relieves symptoms associated with the common cold, flu, hay fever
    and other respiratory allergies
    nasal and sinus congestion
    itching of the nose or throat
    minor aches and pains
    sneezing and runny nose
    itchy, watery eyes
    headaches


  • WARNINGS

    LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER
    DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS
    WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES
    IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER
    DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS
    EVERYDAY WHILE USING THIS PRODUCT



  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.
    Do not exceed 6 doses In a 24 hour period or as directed by a doctor

    children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.
    Do not exceed 5 doses In a 24 hour period or as directed by a doctor

    children under 6 years of ago: consult a doctor

    KEEP OUT OF REACH OF CHILDREN

  • DO NOT USE

    Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product


  • ASK DOCTOR

    Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema,  cough is accompanied by excessive phlegm (mucus),  high blood pressure,  thyroid disease,  glaucoma,  diabetes,  heart disease,  a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland


  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"


  • WHEN USING

    When using this product

    marked drowsiness may occur _ excitability may occur, especially in children

    alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery


  • STOP USE

    Stop use and ask a doctor if
    - nervousness, dizziness or sleeplessness occur,
    - pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur
    _ cough and cold symptoms do not improve within 7 days or recur
    _ symptoms are accompanied by fever that lasts more than 3 days
    _ sore throat is severe or persists for more than 2 days
    _ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.
    These could be signs of a serious condition
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.


  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


  • SPL UNCLASSIFIED SECTION

    Other Information

    _ store at 15'-30'C (59'-86'F)


  • PRINCIPAL DISPLAY PANEL

     
    image of carton

  • INGREDIENTS AND APPEARANCE
    REESES ONETAB ALLERGY AND SINUS 
    acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-812
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    hypromellose (UNII: 3NXW29V3WO)  
    magnesium silicate (UNII: 9B9691B2N9)  
    magnesium stearate (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL (CAPLET) Size 17mm
    Flavor Imprint Code RC;CPE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10956-812-01 1 in 1 CARTON
    1 NDC:10956-812-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/05/2010
    Labeler - REESE PHARMACEUTICAL CO. (004172052)
    Registrant - REESE PHARMACEUTICAL CO. (004172052)
    Establishment
    Name Address ID/FEI Business Operations
    REESE PHARMACEUTICAL CO. 004172052 repack, relabel
    Establishment
    Name Address ID/FEI Business Operations
    CONTRACT PHARMACAL 057795122 manufacture