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DAYTIME NIGHTTIME COLD/FLU RELIEF (A P J Laboratories Limited)

Available Formats

Dosage Form Package Information Links
KIT 1 KIT in 1 PACKAGE (46084-121-01) * 20 TABLET in 1 BLISTER PACK (46084-122-20) * 20 TABLET in 1 BLISTER PACK (46084-123-20) Label Information

Complete DAYTIME NIGHTTIME COLD/FLU RELIEF Information

  • ACTIVE INGREDIENT

    PART 1 OF 2 DAYTIME COLD AND FLU RELIEF

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 10 mg

    Phenylephrine HCl 5 mg





    PART 2 OF 2 NIGHTTIME COLD AND FLU RELIEF

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 10 mg

    Chlorpheniramine Maleate 6.25 mg


  • PURPOSE

    Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine


  • Keep out of reach of children

    Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.


  • USES

    Temporarily relieves common cold/flu symptoms:

    cough due to minor throat and bronchial irritation
    sore throat
    headache
    minor aches and pains
    fever
    runny nose and sneezing (Nighttime only)
    nasal congestion (Daytime only)


  • WARNINGS


    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take

    more than 4 doses in 24 hours, which is the maximum daily amount for these products

    with other drugs containing acetaminophen

    3 or more alcoholic drinks every day while using these products

    Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

    Do not use

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

    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.

    to make a child sleep (Nighttime only)


  • DIRECTIONS


    take only as directed – see Overdose warning

    take Nighttime OR Daytime.

    Nighttime tablets

    do not exceed 4 doses per 24 hours

     adults and children 12 years and over  swallow 2 softgels with water every 6 hrs

     children 4 to under 12 years  ask a doctor

     children under 4 years  do not use

    DayTime tablets

    do not exceed 4 doses per 24 hours

     adults and children 12 years and over  swallow 2 softgels with water every 4 hrs

     children 4 to under 12 years  ask a doctor

     children under 4 years  do not use

    when using other Daytime or Nighttime products, carefully read each label to insure correct dosing



  • INACTIVE INGREDIENT

    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

    STARCH, CORN

    BUTYLATED HYDROXYTOLUENE

    METHYLPARABEN

    PROPYLPARABEN

    SODIUM STARCH GLYCOLATE TYPE A POTATO

    TALC

    MAGNESIUM STEARATE

    SILICON DIOXIDE

    CROSCARMELLOSE SODIUM

    SODIUM LAURYL SULFATE

    ISOPROPYL ALCOHOL

    METHYLENE CHLORIDE

    FD and C YELLOW NO. 6

    HYPROMELLOSES



  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME COLD/FLU RELIEF  A P J
    daytime nighttime cold/flu relief kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-121
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-121-01 1 in 1 PACKAGE
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK 20 
    Part 2 1 BLISTER PACK 20 
    Part 1 of 2
    DAYTIME COLD/FLU RELIEF  A P J
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet
    Product Information
    Item Code (Source) NDC:46084-122
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 30 mg
    STARCH, CORN (UNII: O8232NY3SJ) 12 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) 8 mg
    TALC (UNII: 7SEV7J4R1U) 6 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 6 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 3 mg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 10 mg
    METHYLENE CHLORIDE (UNII: 588X2YUY0A) 20 mg
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 2 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg
    Product Characteristics
    Color pink (LIGHT YELLOWISH PINK) Score 2 pieces
    Shape OVAL (CAPSULE) Size 20mm
    Flavor Imprint Code 425mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-122-20 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2013
    Part 2 of 2
    NIGHTTIME COLD/FLU RELIEF  A P J
    acetaminophen, dextromethorphan hydrobromide, chlorpheniramine maleate tablet
    Product Information
    Item Code (Source) NDC:46084-123
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 6.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 30 mg
    STARCH, CORN (UNII: O8232NY3SJ) 12 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) 8 mg
    TALC (UNII: 7SEV7J4R1U) 6 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 6 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 3 mg
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 10 mg
    METHYLENE CHLORIDE (UNII: 588X2YUY0A) 20 mg
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 2 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL (CAPSULE) Size 20mm
    Flavor Imprint Code 425mg
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-123-20 20 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2013
    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(46084-121)