FACOL COLD AND FLU DAY AND NIGHT (ACETAMINPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, LAC COLOR, GARDENIA BLUE) CAPSULE, LIQUID FILLED [JW HOLDINGS]

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  • FACOL COLD AND FLU DAY AND NIGHT (ACETAMINPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, LAC COLOR, GARDENIA BLUE) CAPSULE, LIQUID FILLED [JW HOLDINGS]

FACOL COLD AND FLU DAY AND NIGHT (ACETAMINPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, LAC COLOR, GARDENIA BLUE) CAPSULE, LIQUID FILLED [JW HOLDINGS]
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NDC 69365-004-01
Set ID 179486ed-7e06-218e-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager JW HOLDINGS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART343
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  • Active Ingredients for DAY (In each capsule).......Purpose Active Ingredients for NIGHT (In each capsule).......Purpose

    Acetaminophen 200mg............................pain reliever/fever reducer

    Guaifenesin 35mg....................................expectorant

    phenylephrine HCl 5mg............................nasal decongestant

    dextromethorphan Hbr8mg.......................cough suppressant

    Acetaminophen 200mg............................pain reliever/fever reducer

    Guaifenesin 35mg....................................expectorant

    phenylephrine HCl 5mg............................nasal decongestant

    dextromethorphan Hbr8mg.......................cough suppressant

    Diphenhyddramine Hydrochloride 18.75mg......antihistamine

  • Uses

    ■ temporary relief of the following cold symptoms ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion ■ cough

  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets in 24 hours. Severe liver damage may occur if you take
    ■ more than 4,000 mg of acetaminophen in 24 hours
    ■ with other drugs containing acetaminophen
    ■ 3 or more alcoholic drinks every day while using this product

  • Do not use

    ■ in children under 12 years of age
    ■ If you ever had an allergic reaction to this product or any of its ingredients.
    ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
    ■ If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist

  • Ask a doctor before use if you have

    ■ liver disease ■asthma, chronic bronchitis or emphysema ■ thyroid disease ■ heart disease ■ diabetes ■ glaucoma ■ high blood pressure

  • Ask a doctor or pharmacist before use if you are

    ■ taking sedatives or tranquilizers ■ having chicken fox or other infections
    ■ taking the blood thinning drug warfarin

  • When using this product

    ■ Do not drink when taking doses ■Do not exceed recommended dose
    ■ be careful when driving motor vehicle (nighttime capsule)

  • Stop use and ask a doctor if

  • If Pregnant or breast-feeding

    do not take this drug and ask a health professional

  • Keep out of reach of children.

  • Overdose warning

    Do not exceed recommended dose. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-333-2333).

  • OtherInformation

    ■ Store between room temperature 20-25°C (68-77°F)
    ■ Avoid direct light or humid condition and excessive heat

  • Inactive Ingredients

  • Questions or Comments?

    1-562-281-5888 Monday-Friday 9AM-4PM EST
    Distributed by: Jemian USA Inc.

  • Directions

    ■ Do not take more than directed

    ■ children under 15 years: ask a doctor
    ■ adults and children 15 years and over: take 2 daytime capsules 2 times a day
    ■ Take 2 nighttime capsules before sleep
    ■ do not take nighttime capsule and daytime capsule together

  • INDICATIONS & USAGE

    temporarily relieves common cold and flu symptoms and minor aches

  • PRINCIPAL DISPLAY PANEL

    facol_daynight_innerNDC 69365-004-01

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
    DO NOT TAKE DAY CAPSULE AND NIGHT CAPSULE TOGETHER

    Facol Cold & Flu Day & Night

    MULTI

    Soft liquid filled capsule

    Guaifenesin-expectorant

    Acetaminophen-Fever/pain reliever

    Phenylephrine HCl-Nasal Decongestant

    Dextromethorphan HBr- Cough Suppressant

    Diphenhydramine HCl-antihistamine (night time capsule only)

    non drowsy Day

    sleep aid Night

    10 capsulesJW Pharmaceuticals

  • INGREDIENTS AND APPEARANCE
    FACOL COLD AND FLU DAY AND NIGHT 
    acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE18.75 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE8 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN35 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L) 206.22 mg
    POVIDONE K29/32 (UNII: 390RMW2PEQ) 33 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 40 mg
    WATER (UNII: 059QF0KO0R) 70.4 mg
    SORBITOL (UNII: 506T60A25R) 142.88 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 440.25 mg
    ALUMINUM OXIDE (UNII: LMI26O6933) 2.185 mg
    COCHINEAL (UNII: TZ8Z31B35M) 2.185 mg
    GARDENIAN BLUE (UNII: 54A6568109) 0.49 
    Product Characteristics
    Coloryellow (soft liquid filled capsule) , blue (soft liquid filled capsule) Scoreno score
    ShapeCAPSULE (rounded liquid filled cap) Size20mm
    FlavorImprint Code FDFN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69365-004-011 in 1 CARTON08/01/2015
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/01/2015
    Labeler - JW HOLDINGS (631094492)
    Registrant - JW HOLDINGS (631094492)
    Establishment
    NameAddressID/FEIBusiness Operations
    RP Bio Inc.689851235manufacture(69365-004) , pack(69365-004) , label(69365-004) , sterilize(69365-004) , analysis(69365-004)
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