Active Ingredient (In Each Banded Capsule)
Diphenhydramine Hydrochloride 50 mg
Diphenhydramine Hcl Capsule
FDA Label NDC 68071-3650
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 68071-3650). 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, use, warnings, otc - do not use, ask a doctor before use if you have, ask a doctor or pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat and nose
- Temporarily relieves these symptoms due to the common cold
- runny nose
- sneezing
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist
before use if you are taking sedatives or tranquilizers
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 of age and over | Take 1 capsule (50 mg) |
| children under 12 years of age | ask a doctor, the proper dosage strength is not available in this package** |
| **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package. | |
Other Information
- Store in a dry place at 15° – 30°C (59° – 86°F).
- Do not use if either capsule band or imprinted safety seal under cap is broken or missing
- Protect from moisture
- Contains lactose
Inactive Ingredients
D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.
Questions?
Questions or comments?1-800-231-4670
Other
Distributed by: MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com
Package Label.Principal Display Panel
Pdp (68071 3650 4)
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