Label: NOREL AD- acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride tablet, multilayer 

  • Label RSS
  • NDC Code(s): 52747-475-70
  • Packager: US Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/13

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active Ingredients (per tablet)

    Acetaminophen 325 mg

    Chlorpheniramine Maleate 4 mg

    Phenylephrine HCl 10 mg

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  • Purpose

    Pain reliever

    Antihistamine

    Nasal decongestant

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  • 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
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  • 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.

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  • 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
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  • 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
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  • 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
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  • 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
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  • 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
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  • If pregnant or breast feeding

    • ask a health professional before use
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  • 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.

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  • 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
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  • 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.

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  • Inactive Ingredients

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

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  • Questions or Comments

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

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  • Principal Display Panel

    Figure 1: Norel® AD container label

    Norel AD container label
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  • INGREDIENTS AND APPEARANCE
    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) ACETAMINOPHEN 325 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 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 YELLOW, WHITE Score no score
    Shape TRIANGLE (Arc) Size 11mm
    Flavor Imprint Code 0425;US
    Contains     
    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
    OTC monograph final part341 04/27/2012
    Labeler - US Pharmaceutical Corporation (048318224)
    Establishment
    Name Address ID/FEI Business Operations
    Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE(52747-475)
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