Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25mg
Pharbedryl Capsule
FDA Label NDC 16103-348
14 label sections · Submitted to the FDA by Pharbest Pharmaceuticals, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Pharbedryl (NDC 16103-348). 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 due to 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 (1-800-222-1222).
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
- store between 20°-25°C (68°-77°F), excursions permitted between 15-30°C (59-86°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 Or Comments?
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Package Label.Principal Display Panel
PHARBEST
NDC 16103-0348-11
Manufactured in the USA
* Compare to the active ingredient in Benadryl® Ultratabs
PHARBEDRYL
Diphenhydramine HCl 25mg
Antihistamine
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat
1000 CAPSULES
This Package for Households without Young Childern
* Please review the disclaimer below.
