FACOL COLD AND FLU DAY AND NIGHT- acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue 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 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
■ temporary relief of the following cold symptoms ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion ■ 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
■ 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
■ 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
■ Do not drink when taking doses ■Do not exceed recommended dose
■ be careful when driving motor vehicle (nighttime capsule)
■ nervousness, dizziness, or sleeplessness, constipation occurs
■ redness or swelling is present ■ fever get worse or lasts more than 3 days
■ new severe symptoms occur ■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose
Do not exceed recommended dose. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-333-2333).
■ Store between room temperature 20-25°C (68-77°F)
■ Avoid direct light or humid condition and excessive heat
purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue, lac color
1-562-695-2818 Monday - Friday 9AM-5PM WET
Distributed by: Bio Mission Group Inc.
■ 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
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
FACOL COLD AND FLU DAY AND NIGHT
acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue 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(69365-004) , pack(69365-004) , label(69365-004) , sterilize(69365-004) , analysis(69365-004) |