REESES ONETAB COLD AND FLU - acetaminophen diphenhydramine hydrochloride phenylephrine hydrochloride tablet 
REESE PHARMACEUTICAL CO.

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.

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DRUG FACTS

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

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.


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)

image of carton

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

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

Revised: 8/2010
Document Id: 36179e63-1f04-41b1-97a5-90c425259f17
Set id: 628f76d8-0bcf-4eb1-a063-061ccf28ccc9
Version: 1
Effective Time: 20100816
 
REESE PHARMACEUTICAL CO.