Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Trigen Laboratories, Inc.
ORAL
OTC DRUG
Antiemetic prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor. • Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland.
OTC monograph final
MECLIZINE HCL- MECLIZINE HYDROCHLORIDE TABLETS TABLET TRIGEN LABORATORIES, 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._ ---------- DRUG FACTS _ACTIVE INGREDIENTS (IN EACH TABLET)_ Meclizine HCl 25 mg _PURPOSE_ Antiemetic _USES:_ prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor. _WARNING:_ 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. KEEP OUT OF REACH OF CHILDREN ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers. WHEN USING PRODUCT • You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery IF PREGNANT OR BREAST FEEDING, ask a Physician before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • ADULTS & CHILDREN 12 YEARS AND OVER: 2-4 tablet once daily • CHILDREN UNDER 12 YEARS: ask a doctor _OTHER INFORMATION_ • EACH TABLET CONTAINS: CALCIUM 51 mg • Store at room temperature 15°-30°C (59°-86°F) INACTIVE INGREDIENTS Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. TRIGEN LABORATORIES MANUFACTURED FOR: TRIGEN Laboratories, Inc., Sayreville, NJ 08872 www.trigenlab.com Rev. 08/13 PRINCIPAL DISPLAY PANEL - 25 MG TABLET LABEL NDC 13811-647-10 MECLIZINE HCL 25 MG 100 TABLETS TRIGEN LABORATORIES MANUFACTURED FOR: TRIGEN Laboratories, Inc., Sayreville, NJ 08872 www.trigenlab.com Rev. 08/13 MECLIZINE HCL meclizine hydrochloride tablets tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRU Прочитайте повний документ