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NDC 63187-0771-20 Diphenhydramine Hydrochloride 25 mg/1 Details
Diphenhydramine Hydrochloride 25 mg/1
Diphenhydramine Hydrochloride is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63187-0771-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 63187-0771 |
|---|---|
| Product ID | 63187-771_880a5683-eb5b-4576-8218-9da10cbd1789 |
| Associated GPIs | 41200030100105 |
| GCN Sequence Number | 011582 |
| GCN Sequence Number Description | diphenhydramine HCl CAPSULE 25 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 45971 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Diphenhydramine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0771-20 (63187077120)
| NDC Package Code | 63187-771-20 |
|---|---|
| Billing NDC | 63187077120 |
| Package | 20 CAPSULE in 1 BOTTLE (63187-771-20) |
| Marketing Start Date | 2017-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 278e5b4b-9495-4269-87f2-8897a48ff6f0 Details
Use
Warnings: Do not use
Ask a doctor before use if you have
When using this product
Pregnancy/breast-feeding warning
Keep out of reach of children
Directions
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 12.5 mg** (1 capsule) every 4 to 6 hours, not more than 6 capsules in 24 hours.
Children under 6 years of age: do not use
**12.5mg dosage strength is not available in this package. Do not attempt to break capsule
Other information
Questions?
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-771) | |