Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Cardinal Health (Leader) 70000
ORAL
OTC DRUG
Nighttime sleep-aid for relief of occasional sleeplessness.
OTC monograph final
NIGHTTIME SLEEP AID MAXIMUM STRENGTH- DIPHENHYDRAMINE HCL CAPSULE CARDINAL HEALTH (LEADER) 70000 _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 PURPOSE Nighttime sleep-aid USE 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 (1- 800-222-1222). 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 between 15-30°C (59-86°F) INACTIVE INGREDIENTS edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol sorbitan* *contains one or more of these ingredient QUESTIONS OR COMMENTS? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST PRINCIPAL DISPLAY PANEL COMPARE TO UNISOM® SLEEPGELS® active ingredient† Sleep Aid Diphenhydramine HCl, 50 mg | Nighttime Sleep-Aid For Relief of Occasional Sleeplessness Non-Habit-Forming SOFTGELS** **One Softgel Per Dose **This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY read_full_document