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 Physicians Total Care, 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 Capsule)
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hydrochloride 50 mg
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
- runny nose and sneezing
- itching of the nose or throat
- itchy, watery eyes.
Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- taking tranquilizers or sedatives
- taking other products containing diphenhydramine
- Do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
Do not use with ny other product containing diphenhydramine, including products used topically.
Ask a doctor or pharmacist before use if you are
When using this product
If pregnant or breastfeeding ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
- Children 12 years and under: Consult a Doctor
Inactive Ingredients
Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.
Storage And Handling
Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured for Sandoz Inc.
Princeton, NJ 08540
Manufactured by Epic Pharma, LLC
Laurelton, NY 11413
L1812
Rev. 11/08
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
How Supplied
DiphenhydrAMINE Hydrochloride Capsules USP
50 mg
| Bottles of 30 | NDC 54868-1050-1 |
| Bottles of 100 | NDC 54868-1050-5 |
Package Label - Principal Display Panel
NDC 54868-1050-1
DiphenhydrAMINE
Hydrochloride
Capsules USP
50 mg
30 Capsules
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