Indications and uses
Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes.
Diphenhydramine HCL
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2023-02-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:37:20
Label at a glance#
ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
Take every 4-6 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 capsule Children under 12 years ask a doctor**25 mg strength is not available in this package. Do not attempt to break capsules.
Storage and handling
Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient(in each capsule)
Diphenhydramine HCL 50 mg
Purpose
Antihistamine
Uses:
- Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
- Sneezing.
- Nasal congestion.
- Runny nose.
- Itchy, watery eyes.
Do not use
- With any other product containing Diphenhydramine HCL, including one applied topically.
Ask a doctor or pharmacist before use
If you haveTrouble urinating due to enlarged prostate glandA breathing problem such as emphysema or chronic bronchitisGlaucomaIf you are taking sedatives or tranquilizers
When using this product
- Avoid alcoholic drinks.
- Marked drowsiness may occur.
- Excitability may occur, especially in children.
- Alcohol, sedatives and tranquilizers may increase drowsiness.
- Be careful when driving a motor vehicle or operating machinery.
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 hoursDo not take more than 6 doses in 24 hours.Adults and children 12 years or over1 capsule Children under 12 years ask a doctor**25 mg strength is not available in this package. Do not attempt to break capsules.
Other information:
- Store at room temperature 15-30 degrees C (59-86 degrees F)
- Protect from excessive moisture
Questions? Adverse drug event call:
1-800-687-0176
HOW SUPPLIED
Product: 50090-4539
NDC: 50090-4539-0 30 CAPSULE in a BOTTLE
NDC: 50090-4539-2 15 CAPSULE in a BOTTLE
NDC: 50090-4539-3 20 CAPSULE in a BOTTLE
NDC: 50090-4539-5 10 CAPSULE in a BOTTLE
NDC: 50090-4539-1 100 CAPSULE in a BOTTLE
Diphenhydramine HCL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-4539-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-1 | 2023-02-07 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-5 | 2023-02-07 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
| 50090-4539-5 | 2023-01-30 | C162847 | 48780-1 | f386c649-d636-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66424-021-01 | EA - Each | 66424-021 | 9776653f-7c63-4b8b-a643-b1ff64504064 | 1 | 2012-07-24 |
| 66424-021-10 | EA - Each | 66424-021 | fa4dd348-3929-4217-a7fb-c7f312f780c8 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine HCL
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FERROSOFERRIC OXIDE
- D&C RED NO. 28
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN, UNSPECIFIED
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- SILICON DIOXIDE
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-4539 | 50090-4539-3, 50090-4539-1, 50090-4539-5, 50090-4539-0, 50090-4539-2 |
| 66424-021 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
Source Document#
openFDA label cross-check#
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 HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 437e6a13-a4ff-4f98-8973-042f224ee85e | 2025-01-13 | Warnings | 66424-021 |
| 4fdde367-23ac-483f-bf52-98da9d06a5fd | 2ea8de9d-069e-4ec6-b536-7f8d9827f338 | 2024-11-05 | Warnings | 2ea8de9d-069e-4ec6-b536-7f8d9827f338 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.