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 n...
Diphenhydramine HCl… 25 mg
Diphenhydramine HCl… 50 mg
Antihistamine
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
50 MG
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
Do not use
25 MG
to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
50 MG
to make a child sleepy
with any other product containing diphenhydramine, including one applied topically
25 MG
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
50 MG
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
before use if you are taking sedatives or tranquilizers
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
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
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.
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
D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.
Questions or comments? (800) 616-2471
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152
| 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 |
|---|---|---|---|---|---|
| 67296-1042-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d4c2-f424-e053-dadaa90a57ce | diph |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-1042-1 | Diphenhydramine Hydrochloride | 24 in 1 BOTTLE | CAPSULE | 24 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-1042 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.] | 2 | Legacy NDC, 1 package rows | 20180426_6ab1c5d2-f7de-5a91-e053-2a91aa0a1fe3.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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67296-1042 | 67296-1042-1 |
| 0904-5306 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| GELATIN | 2G86QN327L | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
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 |
| 6ab1c5d2-f7df-5a91-e053-2a91aa0a1fe3 | 6ab1c5d2-f7de-5a91-e053-2a91aa0a1fe3 | 2018-01-01 | Warnings | 6ab1c5d2-f7df-5a91-e053-2a91aa0a1fe3 6ab1c5d2-f7de-5a91-e053-2a91aa0a1fe3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.