Your browser does not support JavaScript! NOREL AD (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL) TABLET, MULTILAYER [US PHARMACEUTICAL CORPORATION]
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NOREL AD (acetaminophen, chlorpheniramine maleate, and phenylephrine hcl) tablet, multilayer
[US Pharmaceutical Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Drug Facts

Active Ingredients (per tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

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

Warnings

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.

Do not use

  • 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

Ask a doctor before use if you have

  • 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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • 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

Stop use and ask a doctor if

  • 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

If pregnant or breast feeding

  • ask a health professional before use

Keep out of the reach of children.

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.

Directions

  • 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

Other Information

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.

Inactive Ingredients

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

Questions or Comments

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

Principal Display Panel

Figure 1: Norel® AD container label

Norel AD container label
NOREL AD 
acetaminophen, chlorpheniramine maleate, and phenylephrine hcl tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52747-475
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
Product Characteristics
ColorYELLOW, WHITEScoreno score
ShapeTRIANGLE (Arc) Size11mm
FlavorImprint Code 0425;US
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52747-475-7020 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/27/2012
Labeler - US Pharmaceutical Corporation (048318224)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(52747-475)

Revised: 6/2013
 
US Pharmaceutical Corporation

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