FDA Label for Facol Cold And Flu Day
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING:
- USES
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- INACTIVE INGREDIENTS
- DIRECTIONS
- INDICATIONS & USAGE
- ACTIVE INGREDIENT(IN EACH TABLET) PURPOSE
- PRINCILA DISPLAY PANEL
Facol Cold And Flu Day 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.
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
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
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
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
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