FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed By Cardinal Health
Dublin, Ohio 43017
www.myleader.com
Essential to Care™ since 1979
+This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl®
© 2016 Cardinal Health. All rights Reserved. Cardinal Health, the Cardinal Health Logo, Leadear and the Leader Logo are trademarks or registered trademarks of Cardinal Health. All other marks are property of their respective owners.
Active Ingredient
(in each banded capsule)
Diphenhydramine Hydrochloride 25mg
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing; itchy
- watery eyes
- itching of the nose or throat
- runny nose
- sneezing
Temporarily relieves these symptoms due to the common cold:
Do Not Use
- to make child sleepy
- with any other products containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating 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
- use caution 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.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
| adults and children 12 years of age and over | 1 to 2 capsules |
| children 6 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 |
Other Information
- store at room temperature, USP
Inactive Ingredients
D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch
Questions Or Comments
(800) 231-4670
Package Label.Principal Display Panel
NDC 70000-0207-1
Allergy Capsules
Diphenhydramine HCL, 25 mg
Antihistamine
For Allergy Relief
Runny Nose, Itchy Throat, Sneezing and Itchy, Watery Eyes
24 Capsules
Compare to Benadryl® active ingredient+
* Please review the disclaimer below.