FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS]

FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS]
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NDC 69365-001-02
Set ID 0e273007-36ca-320f-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager JW Holdings
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART343
  • 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)

  • 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 exceed recommended dose
    ■ Do not drink when taking doses

  • 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.

  • 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).

  • Uses

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

  • Other Information

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

  • Questions or Comments?

    1-562-281-5888 Monday-Friday 9AM-4PM EST

    Distributed by: Jemian USA Inc.

  • Inactive Ingredients

    purified water, polyethylene glycol 400, propylene glycol, povidone, gelatin, sorbitol, purified water, lac color

  • Warnings

  • Directions

    ■ Do not take more than directed (see overdose warning)
    ■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day
    ■ swallow whole-do not crush, chew or dissolve
    ■ do not take night time capsule in less than 6 hours after taking day time capsule
    ■ children under 15 years: do not use and ask a doctor.

  • INDICATIONS & USAGE

    Relief mild to moderately severe pain, Temporarily reduce multi cold symptom

  • Active Ingredient(in each tablet) Purpose

    Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
    Guaifenesin 35mg…………………………………………………………………………….……...expectorant

    Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant
    Dextromethorphan HBr 8mg…………………………………………………cough suppression

  • PRINCILA DISPLAY PANEL

    NDC 69365-001-01

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    MULTI outer carton design with labels

    Facol® Cold and Flu

    soft liquid filled capsule

    DAY

    Guaifenesin-Expectorant

    Acetaminophen-Fever/Pain Reducer

    Phenylephrine HCl-Nasal Decongestant

    Dextromethorphan HBr-Cough Suppressant

    10 capsules

    JW pharmaceuticals

  • INGREDIENTS AND APPEARANCE
    FACOL COLD AND FLU DAY 
    acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-001
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE8 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 40 mg
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 459 mg
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 40 mg
    GELATIN (UNII: 2G86QN327L) 203.93 mg
    POVIDONE K29/32 (UNII: 390RMW2PEQ) 33 mg
    SORBITOL (UNII: 506T60A25R) 141.1 mg
    COCHINEAL (UNII: TZ8Z31B35M) 2.185 mg
    ALUMINUM OXIDE (UNII: LMI26O6933) 2.185 mg
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code FacD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69365-001-021 in 1 KIT08/01/2015
    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(69365-001) , pack(69365-001) , analysis(69365-001) , label(69365-001)

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