Label: REESES ONETAB COLD AND FLU- acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 16, 2010

If you are a consumer or patient please visit this version.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • 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

  • 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.


    croscarmellose sodium,htpromellose,magnesium silicate,magnesium stearate,

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

    stearic acid,titanium dioxide.
  • SPL UNCLASSIFIED SECTION

    Other Information

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

  • PRINCIPAL DISPLAY PANEL

    image of carton

  • ACTIVE INGREDIENT

    ACETAMINOPHEN 650 mg

    DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

    PHENYLEPHRINE HYDROCHLORIDE 10 MG

    ACETAMINOPHEN 650 mg _ PAIN RELIEVER ; FEVER REDUCER

    DIPHENHYDRAMINE HYDROCHLORIDE 25 mg _ ANTIHISTAMINE

    PHENYLEPHRINE HYDROCHLORIDE 10 mg _ NASAL DECONGESTANT

  • INGREDIENTS AND APPEARANCE
    REESES ONETAB COLD AND FLU 
    acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-813
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVAL (CAPLET) Size17mm
    FlavorImprint Code RC;CPE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-813-011 in 1 CARTON
    1NDC:10956-813-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/05/2010
    Labeler - REESE PHARMACEUTICAL CO. (004172052)
    Registrant - REESE PHARMACEUTICAL CO. (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    REESE PHARMACEUTICAL CO.004172052repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    CONTRACT PHARMACAL057795122manufacture