FACOL COLD AND FLU DAY- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled
JW Holdings
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.
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Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant
Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant
Dextromethorphan HBr 8mg…………………………………………………cough suppression
purified water, polyethylene glycol 400, propylene glycol, povidone, gelatin, sorbitol, purified water, lac color
■ 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
■ 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.
■ liver disease
■ asthma, chronic bronchitis or emphysema
■ thyroid disease
■ heart disease
■ diabetes
■ glaucoma
■ high blood pressure
■ 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)
1-562-695-2818 Monday-Friday 9AM-5PM WET
Distributed by: Bio Mission Group Inc.
■ 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.
■ Store between room temperature 20-25°C (68-77°F)
■ Avoid direct light or humid condition and excessive heat
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 69365-001-01
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
FACOL COLD AND FLU DAY
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled |
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Labeler - JW Holdings (631094492) |
Registrant - JW Holdings (631094492) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
RP Bio Inc. | 689851235 | manufacture(69365-001) , pack(69365-001) , analysis(69365-001) , label(69365-001) , sterilize(69365-001) |