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
Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies: -Sneezing -Nasal congestion -Runny nose -Itchy, watery eyes
Take every 4-6 hours Do not exceed 6 doses in 24 hours. Adults and children 12 years of age or over 25 mg to 50 mg (1 to 2 capsules) Children 6 to under 12 years of age 12.5 mg** to 25 mg (1 capsule) Children under 6 years ask a doctor **12.5 mg dosage strength is not available in this package. Do not attempt to break capsule.
Tamper Evident: Do not use if safety seal under cap is broken or missing Store at controlled room temperature 15°-30°C (59°-86°F) Protect from moisture Use by expiration date on package
Diphenhydramine HCL 25 mg
Antihistamine
Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:
-Sneezing
-Nasal congestion
-Runny nose
-Itchy, watery eyes
If you have
Trouble urinating due to an enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
taking sedatives or tranquilizers
If pregnant or breast-feeding, ask a health professional before use.
Keep out of each of children.
In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Take every 4-6 hours
Do not exceed 6 doses in 24 hours.
Adults and children 12 years of age or over
25 mg to 50 mg
(1 to 2 capsules)
Children 6 to under 12 years of age
12.5 mg** to 25 mg (1 capsule)
Children under 6 years
ask a doctor
**12.5 mg dosage strength is not available in this package.
Do not attempt to break capsule.
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NDC: 70934-445-24
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16103-348-03 | EA - Each | 16103-348 | 5de1d9de-7e1e-4271-80c4-090cadb9fcd8 | 1 | 2012-07-24 |
| 16103-348-08 | EA - Each | 16103-348 | 90cd3e96-3e7f-40bb-a237-08d4664982ea | 1 | 2014-12-01 |
| 16103-348-11 | EA - Each | 16103-348 | 3310a6e3-4317-40ac-a106-9f7606a265f7 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70934-445 | 70934-445-24 |
| 16103-348 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 | 2G86QN327L | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| 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 |
|---|---|---|---|---|---|---|
| Pharbedryl | DIPHENHYDRAMINE HCL | Pharbest Pharmaceuticals, Inc. | 070e556b-e083-452f-8a7c-aca92470dd61 | 2025-12-24 | Warnings | 16103-348 |
| c8267681-7dec-0d56-e053-2995a90a2962 | a7993eaf-648e-a818-e053-2995a90a7ea6 | 2021-07-27 | Warnings | a7993eaf-648e-a818-e053-2995a90a7ea6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.