ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]

ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]
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NDC 46084-101-30
Set ID 44a25c50-b16b-407c-99ea-668afca25924
Category HUMAN OTC DRUG LABEL
Packager A P J Laboratories Limited
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    ACETAMINOPHEN 325 mg

    PHENYLEPHRINE HYDROCHLORIDE 5mg

  • PURPOSE

    •Alleviates Sinus Headache & Pain (Acetaminophen)

    •Relieves Sinus Pressure Clears Nasal Congestion (Phenylephrine HCl)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    for the temporary relief of:

    • headache

    •sinus

    •congestion and pressurenasal congestion

    •minor aches and pains

    •helps decongest sinus openings and passages

    •promotes sinus drainage

    •helps clear nasal passages

  • WARNINGS

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    ■ more than 12 gelcaps 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

    Overdose warning:

    ■ Taking more than the recommended dose (overdose) may cause liver damage.

    ■ In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 and over: Take 2 gelcaps every 4 hoursdo not take more than 12 gelcaps in 24 hours

    ■ Children under 12 years: Do not use this adult product in children under 12 years of age

  • INACTIVE INGREDIENT

    •CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

    •CELLULOSE, MICROCRYSTALLINE

    •STARCH, CORN

    •BUTYLATED HYDROXYTOLUENE

    •METHYLPARABEN

    •PROPYLPARABEN

    •SODIUM STARCH GLYCOLATE TYPE A POTATO

    •TALC

    •MAGNESIUM STEARATE

    •SALICYLIC ACID

    •CROSCARMELLOSE SODIUM

    •SODIUM LAURYL SULFATE

    •ISOPROPYL ALCOHOL

    •METHYLENE CHLORIDE

    •TITANIUM DIOXIDE

    •HYPROMELLOSES

  • PRINCIPAL DISPLAY PANEL

    Product

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN SINUS CONGESTION AND PAIN  A P J COATED
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-101
    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
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 160 mg
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 120 mg
    STARCH, CORN (UNII: O8232NY3SJ) 30 mg
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .5 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) .8 mg
    PROPYLPARABEN (UNII: Z8IX2SC1OH) .4 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 20 mg
    TALC (UNII: 7SEV7J4R1U) 15 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 13 mg
    SALICYLIC ACID (UNII: O414PZ4LPZ) 4 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 7 mg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 130 mg
    METHYLENE CHLORIDE (UNII: 588X2YUY0A) 280 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.5 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-101-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/06/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-101)

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