Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
McKesson
ORAL
OTC DRUG
Nighttime sleep-aid for relief of occasional sleeplessness
OTC monograph final
HEALTH MART NIGHTTIME SLEEP AID- DIPHENHYDRAMINE HYDROCHLORIDE TABLET MCKES S ON _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._ ---------- MCKESSON NIGHTTIME SLEEP AID DRUG FACTS ACTIVE INGREDIENT (IN EACH CAPLET) Diphenhydramine HCl 25 mg PURPOS E Nighttime sleep-aid US E for relief of occasional sleeplessness WARNINGS DO NOT USE • • ASK A DOCTOR BEFORE USE IF YOU HAVE • • • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers WHEN USING THIS PRODUCT • • • STOP USE AND ASK A DOCTOR IF • IF PREGNANT OR BREAST-FEEDING, ask a health professional before 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 trouble urinating due to an enlarged prostate gland glaucoma avoid alcoholic drinks drowsiness may occur do not drive a motor vehicle or operate machinery sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use OTHER INFORMATION • • • INACTIVE INGREDIENTS carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide QUESTIONS OR COMMENTS? 1-800-719-9260 PRINCIPAL DISPLAY PANEL compare to Simply Sleep® Nighttime Sleep Aid active ingredient nighttime sleep aid Diphenhydramine HCl 25 mg contains no pain reliever non-habit forming ACTUAL SI Read the complete document