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

  • NDC Code(s): 52747-475-70
  • Packager: U.S. PHARMACEUTICAL CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 12, 2023

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  • 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

    Allergy alert:Acetaminophen may cause severe skin reaction.
    Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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 (vegetable base), Microcrystalline Cellulose, Povidone K-30, Pregelatinized Starch, Stearic Acid, D&C Yellow #10, FD&C Yellow #6.

  • Questions or Comments

    Please visit www.uspco.comor 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
  • INGREDIENTS AND APPEARANCE
    NOREL AD 
    acetaminophen, chlorpheniramine maleate, and phenylephrine hcl tablet, multilayer
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52747-475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    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; Type 0: Not a Combination Product04/27/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/27/2012
    Labeler - U.S. PHARMACEUTICAL CORPORATION (079467662)