Medication Guide App

REESES ONETAB ALLERGY AND SINUS

Dosage form: tablet
Ingredients: ACETAMINOPHEN 650mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: REESE PHARMACEUTICAL CO.
NDC Code: 10956-812

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 FACTS

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.

Pain Reliever/Fever Reducer

Antihistamine/Cough Suppressant

Nasal Decongestant

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

KEEP OUT OF REACH OF CHILDREN

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

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

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.

Other Information

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

 
REESES ONETAB ALLERGY AND SINUS 
acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-812
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE ) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose 
magnesium silicate 
magnesium stearate 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
STEARIC ACID  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVAL (CAPLET) Size17mm
FlavorImprint CodeRC;CPE
Contains    
Packaging
#Item CodePackage Description
1NDC:10956-812-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:10956-812-3030 TABLET (TABLET) 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/FEIOperations
REESE PHARMACEUTICAL CO.004172052repack, relabel
Establishment
NameAddressID/FEIOperations
CONTRACT PHARMACAL057795122manufacture

Revised: 08/2010
 
REESE PHARMACEUTICAL CO.

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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