Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Safrel Pharmaceuticals, LLC.
ORAL
OTC DRUG
Nighttime sleep-aid provides relief of occasional sleeplessness
OTC monograph final
SLEEP-EZ NIGHTTIME SLEEP AID- DIPHENHYDRAMINE HCL 25 MG TABLET, COATED SAFREL PHARMACEUTICALS, LLC. _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._ ---------- SLEEP-EZ NIGHTTIME SLEEP AID ACTIVE INGREDIENT (IN EACH CAPLET) Diphenhydramine HCl 25 mg PURPOSE Nighttime sleep-aid USES provides 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 with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products ASK A DOCTOR BEFORE USE IF YOU HAVE a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma heart disease ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedative or tranquilizers or any other sleep-aid WHEN USING THIS PRODUCT drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. DIRECTIONS DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING) ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: - take 2 caplets at bedtime if needed or as directed by a doctor CHILDREN UNDER 12 YEARS OF AGE: do not use OTHER I Citiți documentul complet