FDA Label for Diphenhydramine Hcl
View Indications, Usage & Precautions
Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. 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.
Active Ingredient (In Each Banded Capsule)
Diphenhydramine Hydrochloride 50 mg
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
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 (800) 222-1222.
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 at room temperature, USP.
- Do not use if either capsule band or imprinted safety seal under cap is broken
- 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
16 How Supplied
Diphenhydramine HCL capsules are available as follows:
50 mg: pink with red band, capsule, debossed “CPC 836”. Available in bottles of
10 capsules (NDC 43063-720-10)
20 capsules (NDC 43063-720-20)
30 capsules (NDC 43063-720-30)
40 capsules (NDC 43063-720-40)
* Please review the disclaimer below.