Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Western Family Foods, Inc.
ORAL
OTC DRUG
Nighttime sleep-aid for relief of occasional sleeplessness.
OTC monograph final
NIGHTTIME SLEEP AID MAXIMUM STRENGTH- DIPHENHYDRAMINE HCL CAPSULE WESTERN FAMILY FOODS, 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._ ---------- DRUG FACTS ACTIVE INGREDIENT (IN EACH SOFTGEL) Diphenhydramine HCl 50 mg PURPOS E Nighttime sleep-aid PURPOS E Nighttime sleep-aid US E for relief of occasional sleeplessness. WARNINGS DO NOT USE for children under 12 years of age with any other product containing diphenhydramine, even one used on skin ASK A DOCTOR BEFORE USE IF YOU HAVE a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers. WHEN USING THIS PRODUCT avoid alcoholic drinks. STOP USE AND ASK A DOCTOR IF sleeplessness persists continuously for 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. DIRECTIONS adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor OTHER INFORMATION store at 15°-30°C (59°-86°F) INACTIVE INGREDIENTS edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan *may contain this ingredient QUESTIONS OR COMMENTS? Call 1-503-639-6300 MONDAY-FRIDAY 8AM-4PM PST PRINCIPAL DISPLAY PANEL Safe & Effective Fall Asleep FAST! MAXIMUM STRENGTH _**Compare to the Active Ingredient in Unisom® SleepGels®_ Nighttime Sleep Aid Diphenhydramine HCl 50 mg LIQUID FILLED Softgels _1 Softgel Dosage_ **This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®. Proudly Distributed by Western Fam Lestu allt skjalið