Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Randob Labs,Ltd.
ORAL
OTC DRUG
OTC monograph final
DORMIN- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE RANDOB LABS,LTD. _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._ ---------- DRUG FACTS ACTIVE INGREDIENT Diphenhydramine Hydrochloride PURPOS E KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. US ES ▪ WARNINGS ▪ ▪ ▪ ASK DOCTOR AS A DOCTOR BEFORE USE IF YOU HAVE ▪ ▪ ▪ ASK DOCTOR/PHARMACIST AS A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers WHEN USING WHEN USING THIS PRODUCT ▪ STOP USE STOP USE AND ASK A DOCTOR IF sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. helps to reduce difficulty falling asleep DO NOT USE in children under 12 years of age with any other product containing diphenhydramine, even one used on skin a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlarged prostate gland avoid alcoholic drinks PREGNANCY OR BREAST FEEDING IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. DIRECTIONS Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor Children under 12 years of age: Do not give this product to children under 12 years of age OTHER INFORMATION ▪ Use by expiration date on pack INACTIVE INGREDIENTS FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc. PRINCIPAL DISPLAY PANEL Dormin® THE NIGHTTIME SLEEP-AID With Diphenhydramine Hydrochloride • • • 72 Capsules DORMIN diphenhydramine hydrochloride capsule PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:52412-10 0 ROUTE OF ADMINISTRATION ORAL keep in dry place FAST SAFE EFFECTIVE Randob Labs,Ltd. ROUTE OF ADMINISTRATION ACTIVE INGREDIENT/ACTIVE MOIETY INGRED Lestu allt skjalið