DIPHENHYDRAMINE HCL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. - Sneezing. - Nasal congestion. - Runny nose. - Itchy, watery eyes. - With any other product containing Diphenhydramine HCL, including one applied topically. If you have - Trouble urinating due to enlarged prostate gland - A breathing problem such as emphysema or chronic bronchitis - Glaucoma - If you are taking sedatives or tranquilizers

Authorization status:

OTC monograph final

Summary of Product characteristics

DIPHENHYDRAMINE HCL- DIPHENHYDRAMINE HCL CAPSULE
NUCARE PHARMACEUTICALS, 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._
----------
DRUG FACTS
ACTIVE INGREDIENT(IN EACH CAPSULE)
Diphenhydramine HCL 50 mg
PURPOS E
Antihistamine
US ES :
Temporarily relieves these symptoms associated with the common cold,
hay fever, or other
respiratory allergies.
Sneezing.
Nasal congestion.
Runny nose.
Itchy, watery eyes.
WARNINGS :
DO NOT USE
With any other product containing Diphenhydramine HCL, including one
applied topically.
ASK A DOCTOR OR PHARMACIST BEFORE USE
If you have
Trouble urinating due to enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
If you are taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
Avoid alcoholic drinks.
Marked drowsiness may occur.
Excitability may occur, especially in children.
Alcohol, sedatives and tranquilizers may increase drowsiness.
Be careful when driving a motor vehicle or operating machinery.
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 4-6 hours
Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 capsule
Children under 12 years
ask a doctor
**25 mg strength is not available in this package. Do not attempt to
break capsules
OTHER INFORMATION:
Store at room temperature 15-30 degrees C (59-86 degrees F)
Protect from excessive moisture
INACTIVE INGREDIENTS: BLACK IRON OXIDE, D & C RED # 28, FD & C BLUE #
1, FD & C RED # 40,
GELATIN, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, SILICON DIOXIDE,
SODIUM LAURYL SULFATE
QUESTIONS? ADVERSE DRUG EVENT CALL:
1-800-687-0176
DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 26 7-0