BENADRYL diphenhydramine hydrochloride tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

REMEDYREPACK INC.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

                                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._
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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
                                
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