Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25mg
Pharbedryl Capsule
FDA Label NDC 60760-699
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by St. Mary's Medical Park Pharmacy for the product Pharbedryl (NDC 60760-699). 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, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if 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
- itching of the nose or throat
- runny nose
- itchy, watery eyes
- Temporarily relieves these symptoms due to common cold:
- runny nose
- sneezing
Warnings
Do not use
- to make child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor 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 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 91-800-222-1222).
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
| adults and children 12 years and above | 1-2 capsules |
| children 6 to under 12 years | 1 capsule |
| children under 6 years | Ask a doctor |
Other Information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- store between 20°-25°C (68°-77°F)
- protect from excessive moisture
Inactive Ingredients
black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate
Questions?
Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM
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