Active Ingredient(In Each Capsule)
Diphenhydramine HCL 25 mg
Diphenhydramine Hcl
FDA Label NDC 66267-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals, Inc. for the product Diphenhydramine Hcl (NDC 66267-080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(in each capsule), purpose, uses:, do not use, ask a doctor or pharmacist before use, when using this product, if pregnant or breast-feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 to 2 capsule
|
| Children 6 to under 12 years
| 1 capsule
|
| Children under 6 years
| ask a doctor
|
Other Information:
- Store at room temperature 15-30 degrees C (59-86 degrees F)
- Protect from excessive moisture
* Please review the disclaimer below.
