Label: RELIEF-PE- acetaminophen, phenylephrine, chlorpheniramine tablet, coated

  • NDC Code(s): 50332-0153-4, 50332-0153-7
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet):

    Acetaminophen 325mg

    Phenylephrine HCl 5mg

    Chlorpheniramine Maleate 2mg

  • PURPOSE

    Purpose:

    Pain Reliever/Fever Reducer

    Antihistamine

    Nasal Decongestant

  • INDICATIONS & USAGE

    Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:

    • the common cold
    • hay fever
    • upper respiratory allergies
    • headache
    • itchy/watery eyes
    • runny nose
    • muscular aches

    Temporarily reduces fever

  • WARNINGS

    Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4000mg of acetaminophen 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcohol drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
  • DO NOT USE

    Do not use:

    • with any other drug containing acetaminophen (prescription or non-prescription)
    • 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, or if you do not know if your prescription drug contains an MAOI
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if

    • you are taking sedatives or tranquilizers
    • you are taking the blood thinning drug warfarin
    • you do not know if other drugs you are taking contain acetaminophen
  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart, liver, or thyroid disease
    • high blood pressure
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
  • WHEN USING

    When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.

  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs, seek medical help right away
    • you get nervous, dizzy or sleepless
    • new symptom occur
    • fever worsens or lasts for more than 3 days
    • pain or nasal congestion gets worse or lasts more than 7 days
    • redness or swelling is present

    These could be signs of serious condition

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions: Do not take more than directed. Adults and children 12 years of age an over:

    • take 1 to 2 tablets every 6 hours while symptoms persist
    • do not take more than 8 tablets in 24 hours unless directed by a doctor

    Children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT


    corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid

  • PRINCIPAL DISPLAY PANEL

    ReliefPEv24f.jpgReliefPEv24f.jpg

  • INGREDIENTS AND APPEARANCE
    RELIEF-PE 
    acetaminophen, phenylephrine, chlorpheniramine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ275
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0153-4100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product04/16/2012
    2NDC:50332-0153-7250 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product04/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM04/16/2012
    Labeler - HART Health (069560969)
    Registrant - HART Health (069560969)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(50332-0153)