Diphenhydramine HCl
- Dosage form
- CAPSULE
- Labeler
- Cardinal Health 107, LLC
- Label updated
- 2026-04-23
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient (in each banded capsule)
Diphenhydramine HCl… 25 mg
Diphenhydramine HCl… 50 mg
Purpose
Antihistamine
Use
25 MG
-
• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:-
o runny nose -
o sneezing -
o itchy, watery eyes -
o itchy throat and nose
-
-
• Temporarily relieves these symptoms due to the common cold:-
o runny nose -
o sneezing
-
50 MG
-
• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold-
o sneezing -
o runny nose -
o itchy, watery eyes -
o itchy throat and nose
-
WARNINGS
Do not use
25 MG
-
• to make a child sleepy -
• with any other product containing diphenhydramine, even one used on skin
50 MG
-
• to make a child sleepy -
• with any other product containing diphenhydramine, including one applied topically
Ask a doctor before use if you have
25 MG
-
• a breathing problem such as emphysema or chronic bronchitis -
• glaucoma -
• trouble urinating due to an enlarged prostate gland
50 MG
-
• glaucoma -
• a breathing problem such as emphysema or chronic bronchitis -
• difficulty in urination due to enlargement of the 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
25 MG
|
adults and children 12 years of age and over |
1 to 2 capsules |
|
children 6 years to under 12 years of age |
1 capsule |
|
children under 6 years of age |
do not use this product in children under 6 years of age |
50 MG
|
adults and children 12 years of age and over |
1 capsule |
|
children 6 years to 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 at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature] -
• 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? (800) 616-2471
Distributed by
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152
Overbagged with 10 capsules per bag, NDC 55154-0661-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Distributed By:
Cardinal Health
Dublin, OH 43017
L32991870524
|
M-29 |
Rev. 10/16 |
4568-10-16 |
Re-Order No. 008237 |
|
M-29 |
Rev. 10/16 |
4570-10-16 |
Re-Order No. 008239 |
|
M-29 |
Rev. 03/23 |
Re-Order No. 301575 |
Principal Display Panel
NDC 55154-0661-0
DIPHENHYDRAMINE HCl
CAPSULES 50 mg
10 CAPSULES
[Image in the official label — see DailyMed source]
DailyMed Set ID: abc0e348-8532-4658-bd8c-d7dbe5a28c7d · Version 16
NDC: 55154-0661