البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Rugby Laboratories Inc.
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
ORAL
OTC DRUG
Sleep Aid relieves occasional sleeplessness
OTC monograph final
DIPHENHYDRAMINE HCL - DIPHENHYDRAMINE HCL TABLET RUGBY LABORATORIES INC. _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._ ---------- NIGHTTIME SLEEP AID ACTIVE INGREDIENT (IN EACH TABLET) DIPHENHYDRAMINE HCL 50 MG PURPOS E SLEEP AID US ES relieves occasional sleeplessness WARNINGS DO NOT USE with any other product containing diphenhydramine, even one used on skin ASK A DOCTOR BEFORE USE IF YOU HAVE trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers WHEN USING THIS PRODUCT avoid alcoholic drinks STOP AND ASK A DOCTOR IF sleeplessness lasts more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. DIRECTION ADULTS & CHILDREN 12 YEARS AND OVER: one tablet at bedtime CHILDREN UNDER 12 YEARS: ask a doctor OTHER INFORMATION EACH TABLET CONTAINS: calcium 86 mg store at room temperature 15°-30°C (59°-86°F) INACTIVE INGREDIENT croscarmellose sodium, dicalcium phosphate, FD&C blue #1 alum.lake, magnesium stearate, microcrystalline cellulose QUESTIONS OR COMMENTS Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING RUGBY® DULUTH, GEORGIA 30097 PACKAGE LABEL Nighttime sleep aid Diphenhydramine HCl 50 mg Adult Strength NDC 0536-3772-06 50 BLUE TABLETS Rugby Duluth, Georgia 30097 DIPHENHYDRAMINE HCL diphenhydramine hcl tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:0 536 -3772 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIPHENHYDR اقرأ الوثيقة كاملة