Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Reeses Onetab Cold And Flu
FDA Label NDC 10956-813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co. for the product Reeses Onetab Cold And Flu (NDC 10956-813). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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
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