Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Ulai Health LLC
ORAL
OTC DRUG
Nighttime sleep aid - helps reduce difficulty falling asleep - in children under 12 years of age - with any other product containing diphenhydramine, even one used on skin - with other antihistamines - glaucoma - a breathing problem such as emphysema or chronic bronchitis - trouble urinating due to an enlarged prostate gland taking sedatives or tranquilizers. - avoid alcoholic drinks - use caution when driving a motor vehicle or operating machinery sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
OTC monograph final
SLEEP AID- DIPHENHYDRAMINE HCL 25 MG TABLET ULAI HEALTH 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._ ---------- DRUG FACTS ACTIVE INGREDIENT (IN EACH CAPLET) Diphenhydramine HCl 25 mg PURPOSE Nighttime sleep aid USES helps reduce difficulty falling asleep WARNINGS DO NOT USE in children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other antihistamines ASK A DOCTOR BEFORE USE IF YOU HAVE glaucoma a breathing problem such as emphysema or chronic bronchitis 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 use caution 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 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 and over take 2 caplets at bedtime if needed, or as directed by your doctor OTHER INFORMATION each caplet contains: CALCIUM 15 MG store at 20-25 C (68-77 F) INACTIVE INGREDIENTS colloidal silicon dioxide, corn startch, FD&C blue #1, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide QUESTIONS OR COMMENTS? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST) PHARBEST NDC 73057-358-06 MANUFACTURED IN THE USA SAFE, NON-HABIT FORMING SLEEP AID *COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX DIPHENHYDRAMINE HCL 25 MG NIGHTTIME SLEEP AID 50 CAPLETS o o ® SLEEP AID diphenhydramine hcl 25 mg tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC read_full_document