FDA Label for Facol Cold And Flu Day And Night
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS FOR DAY (IN EACH CAPSULE).......PURPOSE ACTIVE INGREDIENTS FOR NIGHT (IN EACH CAPSULE).......PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- IF PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING
- OTHERINFORMATION
- QUESTIONS OR COMMENTS?
- DIRECTIONS
- INDICATIONS & USAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Facol Cold And Flu Day And Night Product Label
The following document was submitted to the FDA by the labeler of this product Jw Holdings. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
If Pregnant Or Breast-Feeding
do not take this drug and ask a health professional
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
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
Package Label.Principal Display Panel
NDC 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
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