Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CHOLINE SALICYLATE (UNII: KD510K1IQW) (SALICYLIC ACID - UNII:O414PZ4LPZ), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
TOPCO ASSOCIATES LLC
ORAL
OTC DRUG
Pain reliever/fever reducer Antihistamine Nasal decongestant nonsteroidal anti-inflammatory drug* temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ temporarily reduces fever
OTC monograph final
TOPCARE NIGHTTIME COLD AND FLU SIMPLE RELIEF- CHOLINE SALICYLATE, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID TOPCO ASSOCIATES LLC _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._ ---------- TOP CARE NIGHTTIME COLD AND FLU SIMPLE RELIEF TOPCARE NIGHTTIME COLD & FLU SIMPLE RELIEF (CHOLINE SALICYLATE, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCL), SOLUTION TOPCO ASSOCIATES LLC -- TOPCO ASSOCIATES LLC. NIGHTTIME COLD & FLU SIMPLE RELIEF DRUG FACTS ACTIVE INGREDIENTS (IN EACH 30 ML) Choline Salicylate (NSAID)* 870 mg Diphenhydramine HCI 50mg Phenylephrine HCl 10 mg PURPOS E Pain reliever/fever reducer Antihistamine Nasal decongestant nonsteroidal anti-inflammatory drug* US ES temporarily relieves these common cold and flu symptoms: ▪ nasal congestion ▪ minor aches and pains ▪ runny nose ▪ sneezing ▪ watery eyes ▪ sore throat ▪ headache ▪ temporarily reduces fever WARNINGS REYE'S SYNDROME Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. ALLERGY ALERT Salicylates (NSAIDs) may cause a severe allergic reaction which may include: ▪ hives ▪ rash ▪ shock ▪ skin reddening ▪ facial swelling ▪ asthma (wheezing) STOMACH BLEEDING WARNINGS This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ▪ are age 60 or older ▪ have had stomach ulcers or bleeding problems ▪ take a blood thinning (anticoagulant) or steroid drug ▪ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ▪ have 3 or more alcoholic drinks every day while using this product ▪ take more or for a long Lue koko asiakirja