Label: FACOL COLD AND FLU NIGHT- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 29, 2022

If you are a consumer or patient please visit this version.

  • 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?

    1-562-695-2818 Monday - Friday 9AM-5PM WET

    Distributed by: Bio Mission Group Inc.

  • 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

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

  • 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

    NDC 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:69365-003-011 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)