Home > Pill Identifier > APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Pill Identifier Information of APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Drug Information

APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Imprint: FR11
Shape: C48348
Color: C48325
Ingredients: Acetaminophen; Chlorpheniramine; Phenylephrine
Size: 11.00
Score: 1
Rxtty: SY
Author: Select Corporation
Inactive Ingredients: POVIDONE K29/32 / SODIUM STARCH GLYCOLATE TYPE A POTATO / CELLULOSE, MICROCRYSTALLINE / STEARIC ACID / MALTODEXTRIN / STARCH, CORN>

Complete Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
    Chlorpheniramine Maleate 2 mg.............................Antihistamine
    Phenylephrine HCl 5 mg.............................Nasal Decongestant



  • PURPOSE

    Pain Reliever, Fever Reducer, Antihistamine, Nasal Decongestant

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older • take 2
    tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or
    as directed by a doctor • Children under 12 years, consult a doctor

  • INDICATIONS & USAGE

    Uses: Temporarily: • relieves nasal congestion associated with sinusitis
    • relieves nasal congestion due to the common cold, hay fever or other
    upper respiratory allergies • relieves sinus congestion and pressure,
    helps decongest sinus openings and passages • restores free breathing
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the
    bronchial passages of bothersome mucus, drain bronchial tubes, and
    make coughs more productive • Temporarily relieves minor aches, pains,
    and fever associated with: • headache • common cold • toothache
    • backache • muscular aches • menstrual cramps

  • WARNINGS

    Warnings: Liver Warning: This
    product contains acetaminophen. Severe liver damage may occur if
    you take: • more than 8 tablets in 24 hours • with other drugs containing
    acetaminophen (prescription or nonprescription). Ask a doctor or
    pharmacist before using with other drugs if you are not sure. • 3 or more
    alcoholic drinks every day while using this product Do not: use with
    any other product containing acetaminophen this will provide more
    than the recommended dose (overdose) of acetaminophen and could
    cause serious health concerns. • use more than the recommended
    dose • for more than 10 days for pain unless directed by a doctor • for
    more than 3 days for fever unless directed by a doctor • 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 MAOI drug. If you do not know if your prescription
    drug contains an MAOI, consult a doctor or pharmacist before
    taking this product. Stop use and ask a doctor if: • symptoms
    do not improve • pain or fever persists or gets worse • new
    symptoms occur • redness or swelling is present • nervousness,
    dizziness or sleeplessness occur • symptoms do not improve within 7
    days or are accompanied by fever Ask a doctor before use if you
    have: • heart disease • high blood pressure • thyroid disease • diabetes
    • difficulty in urination due to enlargement of the prostate gland • a breathing
    problem such as emphysema or chronic bronchitis, or if you have glaucoma
    or difficulty in urination due to enlargement of the prostate gland • may cause
    excitability especially in children • may cause drowsiness; alcohol, sedatives,
    and tranquilizers may increase the drowsiness effect • avoid alcoholic
    beverages while taking this product • do not take this product if you are
    taking sedatives or tranquilizers, without first consulting your doctor • use
    caution when operating machinery.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    Inactive ingredients: FDC Red 40,
    Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
    Glycolate, Starch, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    MM1

    allergy multi symptom packet

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF MULTISYMPTOM  
    acetaminophen,chlorpheniramine maleate, phenylephrine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-457
    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 MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (FR11) Size11mm
    FlavorImprint Code FR11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-457-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - Select Corporation (053805599)