REESES ONETAB COLD AND FLU
Dosage form: tablet
Ingredients: ACETAMINOPHEN 650mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: REESE PHARMACEUTICAL CO.
NDC Code: 10956-813
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.
Keep out of reach of children.
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
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
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 _ 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 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 a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"
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
- 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
If pregnant or breast feeding, ask a health professional before use.
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.
Other Information
_ store at 15'-30'C (59'-86'F)
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
| REESES ONETAB COLD AND FLU
acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet |
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| Labeler - REESE PHARMACEUTICAL CO. (004172052) |
| Registrant - REESE PHARMACEUTICAL CO. (004172052) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| REESE PHARMACEUTICAL CO. | 004172052 | repack, relabel | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| CONTRACT PHARMACAL | 057795122 | manufacture | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.



