FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS]

FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS]
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NDC 69365-003-02
Set ID 104a3cba-6eb2-48b3-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager JW HOLDINGS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART343
  • Active Ingredients (in each tablet) Purpose

    Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
    Guaifenesin 35mg…………………………………………………………………………….……...expectorant
    Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant

    Dextromethorphan HBr 8mg…………………………………………………cough suppression
    Diphenhydramine HCl 15mg………………………………………………..antihistamine

  • Inactive Ingredients

    purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue

  • Uses

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

  • INDICATIONS & USAGE

    Relief cold symptoms and minor pains.

  • Directions

    ■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ Do not take more than directed
    ■ children under 15 years: do not use and ask a doctor.

  • Ask a doctor before usei if

    you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast feeding ■ medical care ■ glaucoma ■ high blood pressure ■ thyroid disease ■ heart disease ■ diabetes

  • Ask a doctor or pharmacist before use if you

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

  • Do not use

    ■ For children who are younger than 3 months old. (new born baby)
    ■ 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) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) 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)

  • Keep out of reach of children.

  • If pregnant or breast-feeding

    Do not take this drug and ask a health professional

  • Questions or Comments?

    Call 1-562-281-5888 Monday - Friday 9AM-4PM Est

  • Stop use and ask a doctor if

    ■ nervousness, dizziness, or sleeplessness, constipation occurs
    ■ redness or swelling is present ■ fever get worse or lasts more than 3 days
    ■ new severe symptoms occur such as shock (anaphylaxis), Stevens Johnson Syndrome, Lyell Syndrome, Asthma, Dyshepatia or Interstitial lung diseases.
    ■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose.

  • When using this product

    ■ Do not exceed recommended dose. Do not drink when taking doses

    ■ Avoid drive or use of machineries.

  • Other Information

  • 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).

  • PRINCIPAL DISPLAY PANEL

    FACOL_NIGHT_INNERCASENDC 69365-003-01

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Facol Cold & Flu Night

    MULTI

    Soft liquid filled capsule

    Guaifenesin-Expectorant

    Acetaminophen-Fever/pain reliever

    Phenylephrine HCl-Nasal Decongestant

    Dextromethorphan HBr- Cough Suppressant

    Diphenhydramine HCl-Antihistamine

    sleep aid

    10 capsules

    JW Pharmaceuticals

  • INGREDIENTS AND APPEARANCE
    FACOL COLD AND FLU NIGHT 
    acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN35 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE8 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE18.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    GARDENIAN BLUE (UNII: 54A6568109) 0.49 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 440.25 mg
    WATER (UNII: 059QF0KO0R) 70.4 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 40 mg
    POVIDONE K29/32 (UNII: 390RMW2PEQ) 33 mg
    GELATIN (UNII: 2G86QN327L) 206.22 mg
    SORBITOL (UNII: 506T60A25R) 142.88 mg
    Product Characteristics
    Colorblue (Light bluish liquid filled soft gel) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code FacN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69365-003-021 in 1 CARTON08/01/2015
    11 in 1 BLISTER PACK
    110 in 1 CAPSULE; 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(69365-003) , pack(69365-003) , analysis(69365-003) , label(69365-003) , sterilize(69365-003)

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