Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Natco Pharma USA LLC
ORAL
OTC DRUG
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat
Each 5 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 12.5mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-151-05 (1) unit dose cup 5mL NDC 69339-151-17 40 (4x10) unit dose cups 5mL NDC 69339-151-19 100 (10x10) unit dose cups 5mL Each 10 mL of Diphenhydramine Hydrochloride Oral Solution, USP contains 25mg diphenhydramine hydrochloride and is supplied in the following oral dosage forms: NDC 69339-152-01 (1) unit dose cup 10mL NDC 69339-152-17 40 (4x10) unit dose cups 10mL NDC 69339-152-19 100 (10x10) unit dose cups 10mL
OTC monograph final
DIPHENHYDRAMINE HCL ORAL SOLUTION- DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION NATCO PHARMA USA LLC ---------- DIPHENYDRAMINE HCL ORAL SOLUTION, USP _DRUG FACTS_ ACTIVE INGREDIENT (IN EACH 5 ML) Diphenhydramine HCl USP 12.5 mg ACTIVE INGREDIENT (IN EACH 10 ML) Diphenhydramine HCl USP 25 mg PURPOSE Antihistamine USES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat WARNINGS DO NOT USE • in neonates or premature infants • if pregnant or breast-feeding • if hypersensitive to diphenhydramine HCI and other similar antihistamine • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy ASK A DOCTOR BEFORE USE IF YOU HAVE • glaucoma • a breathing problem such as emphysema or chronic bronchitis • a sodium restricted diet • trouble urinating due to enlarged prostate gland ASK A DOCTOR OR PHARMACIST BEFORE USE if you are taking tranquilizers or sedatives WHEN USING THIS PRODUCT • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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 • Use the following dosage guidelines when using this product AGE (YR) DOSE (ML) Adults and children 12 years and older take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours. Children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours Children under 6 years ask a doctor OTHER INFORMATION • each 5mL contains sodium 10mg • each 10mL contains sodium 20mg • alcohol free, cherry flavor • store at 20-25°C (68-77°F) • protect from excessive moisture • do not use if lid seal is open or damaged • see top of cup for lot number and expiration date INACTIVE Soma hati kamili