NDC 0904-2056 Diphenhydramine Hydrochloride
Capsule Oral
Product Information
What is NDC 0904-2056?
The NDC code 0904-2056 is assigned by the FDA to the product Diphenhydramine Hydrochloride which is a human over the counter drug product labeled by Major Pharmaceuticals. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 0904-2056-61 10 blister pack in 1 box / 10 capsule in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Diphenhydramine Hydrochloride?
This product is used as Antihistamine
Product Characteristics
Color(s) | PINK (C48328 - HALF PINK AND HALF CLEAR WITH WHITE POWDER INSIDE, BANDED IN RED AROUND THE MIDDLE) PINK (C48328 - PINK, BANDED IN RED AROUND THE MIDDLE) |
Shape | CAPSULE (C48336) |
Size(s) | 14 MM |
Imprint(s) | CPC;835 CPC;836 |
Score | 1 |
Product Packages
NDC Code 0904-2056-61
Package Description: 10 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK
Price per Unit: $0.02183 per EA
Product Details
What are Diphenhydramine Hydrochloride Active Ingredients?
- DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
Diphenhydramine Hydrochloride Active Ingredients UNII Codes
- DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
- DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1020477 - diphenhydrAMINE HCl 50 MG Oral Capsule
- RxCUI: 1020477 - diphenhydramine hydrochloride 50 MG Oral Capsule
- RxCUI: 1020477 - diphenhydramine HCl 50 MG Oral Capsule
- RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
- RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
Diphenhydramine Hydrochloride Inactive Ingredients UNII Codes
- D&C RED NO. 28 (UNII: 767IP0Y5NH)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GELATIN (UNII: 2G86QN327L)
- LACTOSE (UNII: J2B2A4N98G)
- STARCH, CORN (UNII: O8232NY3SJ)
Pharmacologic Class(es)
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Patient Education
Diphenhydramine
Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
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Diphenhydramine Hydrochloride Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
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:
- runny nose
- sneezing
- itchy, watery eyes
- itchy throat and nose
- Temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat and nose
50 MG
Warnings
Do not use
25 MG
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- with any other product containing diphenhydramine, including one applied topically
50 MG
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
50 MG
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
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