Active Ingredient(In Each Banded Capsule)
Diphenhydramine HCL 25 mg
Pharbedryl
FDA Label NDC 67046-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Pharbedryl (NDC 67046-007). 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 banded capsule), purpose, uses:, do not use, ask a doctor or pharmacist before use, ask a doctor or pharmacist before use of you are, when using this product, if pregnant or breast-feeding,, 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, even one used on skin.
Ask A Doctor Or Pharmacist Before Use
If you have
- Trouble urinating due to an enlarged prostate gland
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
Ask A Doctor Or Pharmacist Before Use Of 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 accidental overdose, get medical help or contact a Poison Control Center immediately.
Directions:
- Take every 4-6 hours
- Do not exceed 6 doses in 24 hours.
| Adults and children 12 years of age or over
| 25 mg to 50 mg
(1 to 2 capsules) |
| Children 6 to under 12 years of age
| 12.5 mg** to 25 mg (1 capsule)
|
| Children under 6 years
| ask a doctor
|
**12.5 mg dosage strength is not available in this package.
Do not attempt to break capsule.
Other Information:
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- Store at controlled room temperature 15°-30°C (59°-86°F)
- Protect from moisture
- Use by expiration date on package
Questions? Adverse Drug Event Call: (866)562-2756
Enter section text here
* Please review the disclaimer below.
