البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
JW HOLDINGS
ACETAMINOPHEN
ACETAMINOPHEN 200 mg
ORAL
OTC DRUG
Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer Guaifenesin 35mg…………………………………………………………………………….……...expectorant Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant Dextromethorphan HBr 8mg…………………………………………………cough suppression Diphenhydramine HCl 15mg………………………………………………..antihistamine ■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ cough Relief cold symptoms and minor pains. you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast feeding ■ medical care ■ glaucoma ■ high blood pressure ■ thyroid disease ■ heart disease ■ diabetes ■ 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
OTC monograph not final
FACOL COLD AND FLU NIGHT- ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL 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._ ---------- FACOL COLD AND FLU NIGHT _ACTIVE INGREDIENTS (IN EACH TABLET) PURPOSE_ Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer Guaifenesin 35mg……………………………………………………………………………. ……...expectorant Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant Dextromethorphan HBr 8mg…………………………………………………cough suppression Diphenhydramine HCl 15mg………………………………………………..antihistamine _INACTIVE INGREDIENTS_ purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue _USES_ ■ temporary relief of the following cold symptoms. ■ sore throat ■ minor aches and pains ■ headache ■ fever ■ nasal congestion ■ sinus congestion and pressure ■ 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 INDICATIONS & USAGE Relief cold symptoms and minor pains. _DIRECTIONS_ _DIRECTIONS_ ■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ Do not take more than directed ■ children under 15 years: do not use and ask a doctor. _ASK A DOCTOR BEFORE USEI IF_ you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast اقرأ الوثيقة كاملة