Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
REMEDYREPACK INC.
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
OTC DRUG
OTC monograph final
BENADRYL- DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED REMEDYREPACK 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._ ---------- BENADRYL _DRUG FACTS_ ACTIVE INGREDIENT (IN EACH TABLET) Diphenhydramine HCl 25 mg PURPOS E Antihistamine US ES temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing WARNINGS DO NOT USE to make a child sleepy with any other product containing diphenhydramine, even one used on skin ASK A DOCTOR BEFORE USE IF YOU HAVE a breathing problem such as emphysema or chronic bronchitis glaucoma 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 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 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 take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use OTHER INFORMATION EACH TABLET CONTAINS: calcium 15 mg store between 20-25°C (68-77°F). Protect from light. DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS BROKEN INACTIVE INGREDIENTS carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene gl Read the complete document