Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Salado Sales, Inc.
ORAL
OTC DRUG
Nighttime sleep-aid - for relief of occasional sleeplessness - reduces time to fall asleep if you have difficulty falling asleep
OTC monograph final
SLEEP- DIPHENHYDRAMINE HCL TABLET SALADO SALES, 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._ ---------- CVP 44-189 _ACTIVE INGREDIENT (IN EACH TABLET)_ Diphenhydramine HCl 25 mg _PURPOSE_ Nighttime sleep-aid _USES_ for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep _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 difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers. WHEN USING THIS PRODUCT avoid alcoholic beverages. 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_ DO NOT TAKE MORE THAN DIRECTED adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use _OTHER INFORMATION_ EACH TABLET CONTAINS: calcium 60 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number _INACTIVE INGREDIENTS_ croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid _QUESTIONS OR COMMENTS?_ 1-800-426-9391 _PRINCIPAL DISPLAY PANEL_ NIGHTTIME SLEEP AID WAKE RESTED AND REFRESHED COMPARE TO ORI Lesen Sie das vollständige Dokument