The following Structured Product Label (SPL) was submitted to the FDA by Jw Holdings for the product Facol Cold And Flu Night (NDC 69365-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each tablet) purpose, inactive ingredients, uses, warnings, indications & usage, directions, ask a doctor before usei if, ask a doctor or pharmacist before use if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant
Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant
Dextromethorphan HBr 8mg…………………………………………………cough suppression
Diphenhydramine HCl 15mg………………………………………………..antihistamine
purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue
■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ cough
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
Relief cold symptoms and minor pains.
■ 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.
you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast feeding ■ medical care ■ glaucoma ■ high blood pressure ■ thyroid disease ■ heart disease ■ diabetes
■ taking sedatives or tranquilizers ■ having chicken fox or other infections
■ taking the blood thinning drug warfarin
■ 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)
Do not take this drug and ask a health professional
Call 1-562-281-5888 Monday - Friday 9AM-4PM Est
■ 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.
■ Do not exceed recommended dose. Do not drink when taking doses
■ Avoid drive or use of machineries.
Do not exceed recommended dose. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-333-2333).
NDC 69365-003-01
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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
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