Norel AD description, usages, side effects, indications, overdosage, supplying and lots more!

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Norel AD

US Pharmaceutical Corporation




FULL PRESCRIBING INFORMATION

Acetaminophen 325 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Pain reliever

Antihistamine

Nasal decongestant

Temporarily relieves these symptoms due to the common cold or flu

  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sore throat
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • sinus congestion and pressure
  • temporarily reduces fever

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, speak with a healthcare provider.

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • taking the blood thinning drug warfarin
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers
  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • ask a health professional before use

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 1 tablet every 4 hours, while symptoms persist
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor

store at 20°-25°C (68°-77°F)

Overdose Warning: Keep this and all medication out of the reach of children. In case of accidental overdose, seek medical help or contact a Poison Control Center immediately.

Colloidal Silicon Dioxide, Crospovidone Polyplasdone, Magnesium Stearate NF vegetable base, Microcrystalline Cellulose NF, Povidone K-30, Yellow Lake Blend

Please visit www.uspco.com or contact us at US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

Figure 1: Norel® AD container label

Norel AD

Norel AD

acetaminophen, chlorpheniramine maleate, and phenylephrine HCl TABLET, MULTILAYER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52747-475
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 4 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30
D&C YELLOW NO. 10
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm 0425;US TRIANGLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52747-475-70 20 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-04-27


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