FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(In Each Capsule)
Diphenhydramine HCL 50 mg
Purpose
Antihistamine
Uses:
- 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
Questions? Adverse Drug Event Call:
1-800-687-0176
* Please review the disclaimer below.