1. Home
  2. Labeler Index
  3. Reese Pharmaceutical Co.
  4. 10956-813
  5. Label Information: Reeses Onetab Cold And Flu

FDA Label for Reeses Onetab Cold And Flu

View Indications, Usage & Precautions

Table of Contents

    1. OTC - KEEP OUT OF REACH OF CHILDREN
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. DOSAGE & ADMINISTRATION
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OVERDOSAGE
    12. INACTIVE INGREDIENT
    13. OTHER
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    15. OTC - ACTIVE INGREDIENT
    16. OTC - PURPOSE

Reeses Onetab Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Reese Pharmaceutical Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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


Otc - 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


Otc - 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


Otc - Ask Doctor/Pharmacist



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


Otc - 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


Otc - 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

Otc - 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.


Inactive Ingredient



Croscarmellose sodium,htpromellose,magnesium silicate,magnesium stearate,microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,stearic acid,titanium dioxide.

Other



Other Information

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


Package Label.Principal Display Panel



image of carton - ReesesOneTabCPEC201008160001

image of carton - ReesesOneTabCPEC201008160001


Otc - Active Ingredient



ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE 25 mgPHENYLEPHRINE HYDROCHLORIDE 10 MG

Otc - Purpose



ACETAMINOPHEN 650 mg _ PAIN RELIEVER ; FEVER REDUCER

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg _ ANTIHISTAMINE

PHENYLEPHRINE HYDROCHLORIDE 10 mg _ NASAL DECONGESTANT


* Please review the disclaimer below.