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Facol Cold and Flu Day (acetaminophen 200 mg guaifenesin 35 mg dextromethorphan hydrobromide 8 mg phenylephrine hydrochloride 5 mg water 40 mg polyethylene glycol 400 459 mg propylene glycol 40 mg gelatin 203.93 mg povidone k29/32 33 mg sorbitol 141.1 mg cochineal 2.185 mg aluminum oxide 2.185 mg) Dailymed


Generic: acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: FACD     SHAPE: oval
    COLOR: yellow

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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

Inactive Ingredients


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

Uses


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

â–  more than 4,000 mg of acetaminophen in 24 hours â–  with other drugs containing acetaminophen

â–  3 or more alcoholic drinks every day while using this product

Indications & Usage


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

Directions


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

Ask A Doctor Before Use If You Have


â–  liver disease â–  asthma, chronic bronchitis or emphysema â–  thyroid disease â–  heart disease

â–  diabetes

â–  glaucoma

â–  high blood pressure

Ask A Doctor Or Pharmacist Before Use If You Are


â–  taking sedatives or tranquilizers â–  having chicken fox or other infections â–  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


â–  nervousness, dizziness, or sleeplessness, constipation occurs â–  redness or swelling is present â–  fever get worse or lasts more than 3 days â–  new severe symptoms occur such as shock (anaphylaxis), Stevens Johnson Syndrome, Lyell Syndrome, Asthma, Dyshepatia or Interstitial lung diseases. â–  pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose.

When Using This Product


â–  Do not exceed recommended dose â–  Do not drink when taking doses

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).

Princila Display Panel


NDC 69365-001-01

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Facol® Cold and Flu Day

MULTI

Soft liquid-filled capsule

Guaifenesin-Expectorant

Acetaminophen-Fever/Pain Reducer

Phenylephrine HCl-Nasal Decongestant

Dextromethorphan HBr-Cough Suppressant

10 capsules

JW pharmaceuticals

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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