DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine  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 

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_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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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES 25MG
ACTIVE INGREDIENT (IN EACH BANDED CAPSULE)
Diphenhydramine HCl 25
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
• glucoma
• 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.
DIRECTIONS
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 1 to 2 capsules
children 6 to under 12 years of age
1 capsule
children under 6 years of age
do not use this product in children under 6 years of age
OTHER INFORMATION
• store at room temperature, see USP
• do not use if either capsule band or imprinted safety seal under
cap is broken or missing
• protect from moisture
• contains lactose
INACTIVE