Label: ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED- acetaminophen, phenylephrine hydrochloride tablet

  • NDC Code(s): 46084-101-30
  • Packager: A P J Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 6, 2013

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  • ACTIVE INGREDIENT

    ACETAMINOPHEN 325 mg

    PHENYLEPHRINE HYDROCHLORIDE 5mg

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  • PURPOSE

    •Alleviates Sinus Headache & Pain (Acetaminophen)

    •Relieves Sinus Pressure Clears Nasal Congestion (Phenylephrine HCl)

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • 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

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  • 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.

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN SINUS CONGESTION AND PAIN  A P J COATED
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-101
    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 HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score 2 pieces
    Shape OVAL Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-101-30 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/06/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories Limited 677378339 manufacture(46084-101)
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