Indications and uses
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.
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.
Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours. Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours. Children under 6 years of age: ask a doctor
Diphenhydramine Hydrochloride 25 mg & 50 mg
Antihistamine
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.
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.
glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.
taking taking tranquilizers or sedative.
you may get drowsy; 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. Do not use any other products containing diphenhydramine.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222
Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.
Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.
Children under 6 years of age: ask a doctor
Store at controlled room temperature 59-86 degrees F.
Lactose, starch, gelatin with bisulfites and artificial colors.
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.
call toll free 734-743-6000
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--08/2010--NJW
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1049909 | diphenhydrAMINE HCl 25 MG Oral Capsule | PSN | 1 |
| 1020477 | diphenhydrAMINE HCl 50 MG Oral Capsule | PSN | 1 |
| 1049909 | diphenhydramine hydrochloride 25 MG Oral Capsule | SCD | 1 |
| 1020477 | diphenhydramine hydrochloride 50 MG Oral Capsule | SCD | 1 |
| 1020477 | diphenhydramine HCl 50 MG Oral Capsule | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67046-125-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d42e-621f-e053-dbdaa90a74ad | Diphendydramine Hydrochloride Capsules |
| 67046-126-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d42e-621f-e053-dbdaa90a74ad | Diphendydramine Hydrochloride Capsules |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-125-30 | DIPHENDYDRAMINE HYDROCHLORIDE | 30 in 1 BLISTER PACK | CAPSULE | 30 | 1 | |
| 67046-126-30 | DIPHENDYDRAMINE HYDROCHLORIDE | 30 in 1 BLISTER PACK | CAPSULE | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67046-125 | DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA] | 1 | Legacy NDC, 1 package rows | 20100809_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e.zip |
| 67046-126 | DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE [CONTRACT PHARMACY SERVICES-PA] | 1 | Legacy NDC, 1 package rows | 20100809_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5306-24 | EA - Each | 0904-5306 | b0edee36-ed2f-4648-b6e0-36b1ba93f7e6 | 1 | 2019-05-02 |
| 0904-5306-60 | EA - Each | 0904-5306 | 555c059d-810d-4ef2-9c17-83fdd1a60d90 | 1 | 2013-02-11 |
| 0904-5306-61 | EA - Each | 0904-5306 | 79119dfd-637d-4b1f-a12c-6fcdcad21332 | 1 | 2012-07-24 |
| 0904-5306-80 | EA - Each | 0904-5306 | 0b4a65cc-9c47-45af-bead-889c34a79814 | 1 | 2013-02-11 |
| 0904-5307-60 | EA - Each | 0904-5307 | fbc100c3-1d2e-4360-bd2f-a92b1e556d3b | 1 | 2013-02-11 |
| 0904-5307-80 | EA - Each | 0904-5307 | 602b6862-e0e7-4d9b-bcb4-48a7a3eba316 | 1 | 2013-02-11 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67046-125 | 67046-125-30 |
| 0904-5306 | |
| 67046-126 | 67046-126-30 |
| 0904-5307 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 04e70311-6412-4a20-84e3-f6e26d5f19ab | 2026-02-20 | Warnings | 0904-5306 |
| Banophen | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 7f2b72cc-d4f7-431f-be61-c103cf8c489e | 2026-02-20 | Warnings | 0904-5307 |
| 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e | 2010-07-30 | Warnings | 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e 1d026ead-c3de-4dc6-9d3c-5a603f6dde4e |
Adverse event summaries are temporarily unavailable. Other product information remains available.