REESES ONETAB ALLERGY AND SINUS description, usages, side effects, indications, overdosage, supplying and lots more!

REESES ONETAB ALLERGY AND SINUS

REESE PHARMACEUTICAL CO.
REESE PHARMACEUTICAL CO.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DRUG FACTS



FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 650 mg
Diphenhydramine Hydochloride 25 mg
Phenylephrine Hydrochloride 10 mg





Purpose

Pain Reliever/Fever Reducer

Antihistamine/Cough Suppressant

Nasal Decongestant

Uses

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








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 Type Human otc drug label Item Code (Source) NDC:10956-812
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
hypromellose
magnesium silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
titanium dioxide
CROSCARMELLOSE SODIUM
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 17 mm RC;CPE OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10956-812-30 30 in 1 BOTTLE, PLASTIC
2 NDC:10956-812-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-04-05


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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