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Relief-PE (NorMed)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 250 TABLET, COATED in 1 BOX, UNIT-DOSE (50332-0127-7) Label Information
TABLET, COATED 100 TABLET, COATED in 1 BOX, UNIT-DOSE (50332-0127-4) Label Information

Complete Relief-PE Information

  • 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 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcohol drinks every day while using this product

  • 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

    • 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 mo rethan 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: do not use; this will provide more than the recommended does (overdose) and may cause liver damage

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet)

    Acetaminophen 325mg...pain reliever/fever reducer

    Phenylephrine 5mg...nasal decongestant

    chlorpheniramine maleate 2mg...antihistimine


  • PURPOSE

    Pain Reliever/Fever Reducer

    Nasal Decongestant

    Antihistamine


  • INACTIVE INGREDIENT


    corn starch, hydroxpropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, stearic acid

  • INGREDIENTS AND APPEARANCE
    RELIEF-PE 
    acetaminophen, phenylephrine, chlorpheniramine tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0127
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code AZ275
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50332-0127-4 100 in 1 BOX, UNIT-DOSE
    2 NDC:50332-0127-7 250 in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/16/2012
    Labeler - NorMed (069560969)