Country: United States
Language: English
Source: NLM (National Library of Medicine)
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Pharmacy Value Alliance, LLC
ORAL
OTC DRUG
Antiemetic For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness
OTC monograph final
MOTION SICKNESS RELIEF- MECLIZINE HCL TABLET PHARMACY VALUE ALLIANCE, 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._ ---------- PV 778AU (478) ACTIVE INGREDIENT (IN EACH TABLET) Meclizine HCI 25mg PURPOSE Antiemetic USES For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness WARNINGS DO NOT USE in children under 12 years of age unless directed by a doctor. ASK A DOCTOR BEFORE USE IF YOU HAVE • breathing problems, such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland A SK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers. WHEN USING THIS PRODUCT • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery I F 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 • to prevent motion sickness, take the first dose 1/2 to 1 hour before starting activity • not for frequent or prolonged use except on the advice of a doctor • do not exceed recommended dose Adults and children 12 years of age and older Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. OTHER INFORMATION • TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing. • store at room temperature 15˚-30˚C (59˚-86˚F) • protect from heat and humidity INACTIVE INGREDIENTS D&C yellow # 10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica QUESTIONS OR COMMENTS? 1-800-540-3765 PACKAGE LABEL MOTION SICKNESS RELIEF meclizine hcl tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURC Read the complete document