Dosage and administration
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours children under 12 years: ask a doctor
Diphenhydramine Hydrochloride
- Manufacturer
- RedPharm Drug, Inc.
- Effective date
- 2020-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:18
Label at a glance#
ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections
Label contents#
Full prescribing information#
DRUG FACTS
.
ACTIVE INGREDIENT
(in each capsule)
Diphenhydramine HCl 25 mg
PURPOSE
Antihistamine
INDICATIONS & USAGE
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
runny nose
itchy nose or throat
sneezing
itchy, watery eyes
WARNINGS
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
you may get very drowsy
avoid alcoholic drinks
alcohol, sedatives & 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
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor
OTHER INFORMATION
store at 15-30 °C (59-86 °F)
protect from moisture
For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
INACTIVE INGREDIENTS
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate
QUESTIONS OR COMMENTS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.
DOSAGE & ADMINISTRATION
adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
children under 12 years: ask a doctor
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-1055-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-eccd-a426-e053-dadaa90af4c2 | diphenhydramine |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-1055-1 | Diphenhydramine Hydrochloride | 24 in 1 BOTTLE | CAPSULE | 24 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-1055 | DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.] | 3 | Legacy NDC, 1 package rows | 20200121_6ab14206-d66b-441a-e053-2a91aa0a0052.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-3339-21 | EA - Each | 0603-3339 | e2c93408-9328-4e7c-a395-f51f58d99251 | 1 | 2013-02-13 |
| 0603-3339-32 | EA - Each | 0603-3339 | 4b90952e-b661-4a90-9202-84b5a29a00ca | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine Hydrochloride
- MAGNESIUM STEARATE
- PROPYLPARABEN
- FD&C BLUE NO. 1
- GELATIN
- LACTOSE, UNSPECIFIED FORM
- ANHYDROUS LACTOSE
- POLYSORBATE 80
- DIPHENHYDRAMINE
- BENZYL ALCOHOL
- BUTYLPARABEN
- D&C RED NO. 28
- FD&C RED NO. 40
- METHYLPARABEN
- SODIUM LAURYL SULFATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67296-1055 | 67296-1055-1 |
| 0603-3339 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| D&C RED NO. 28 | 767IP0Y5NH | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | 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 |
|---|---|---|---|---|---|---|
| 9c9ed8d1-9a64-e2d6-e053-2995a90a93ce | 6ab14206-d66b-441a-e053-2a91aa0a0052 | 2020-01-20 | Warnings | 9c9ed8d1-9a64-e2d6-e053-2995a90a93ce 6ab14206-d66b-441a-e053-2a91aa0a0052 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.