Label: ACETAMINOPHEN PHENYLEPHRINE HCL- acetaminophen 500mg phenylephrine hcl 5mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 16, 2014

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

  • Active ingredient

    Acetaminophen 500 mg
    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever
    Nasal decongestant

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  • Uses

    temporarily relieves nasal and sinus congestion temporarily relieves minor aches and pains, headaches

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  • 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 alcoholic drinks every day while using this product

    Do Not Use

    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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

    Ask Doctor before use if you have

    liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

    Ask Doctor/Pharmacist before use if you

    are taking the blood thinning drug warfarin

    When Using

    do not use more than directed

    Stop use and ask a doctor if

    redness or swelling is presentnew symptoms occur you get nervous, dizzy, or sleepless pain gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 daysYou may report side effects to 800-952-0050

    If pregnant or Breast Feeding

    ask a health professional before use

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  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt 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

    Adults and children 12 years of age and older: take 2 tablets every 4-6 hours Do not take more than 8 tablets in 24 hours Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems

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  • Other information

    store at room temperature in a dry place do not use if blister package is torn

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  • Inactive Ingredients

    corn starch, crospovidone, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN PHENYLEPHRINE HCL 
    acetaminophen 500mg phenylephrine hcl 5mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-261
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code AZ;261
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69168-261-99 23437 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/01/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    Name Address ID/FEI Business Operations
    Allegiant Health 079501930 ANALYSIS(69168-261) , LABEL(69168-261) , MANUFACTURE(69168-261) , PACK(69168-261) , RELABEL(69168-261) , REPACK(69168-261)
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