Search by Drug Name or NDC
NDC 00363-9895-48 Diphenhydramine Hydrochloride 50 mg/1 Details
Diphenhydramine Hydrochloride 50 mg/1
Diphenhydramine Hydrochloride is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. 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: 00363-9895-48Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 00363-9895 |
|---|---|
| Product ID | 0363-9895_b792bc1d-0578-d993-e053-2995a90a7913 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | WALGREENS |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part338 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 00363-9895-48 (00363989548)
| NDC Package Code | 0363-9895-48 |
|---|---|
| Billing NDC | 00363989548 |
| Package | 48 CAPSULE in 1 BOTTLE (0363-9895-48) |
| Marketing Start Date | 2017-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4deea234-0585-1595-e054-00144ff88e88 Details
Do Not Use
Ask a doctor before use if you have
Stop use and ask a doctor if
Keep out of the reach of children
Directions
Other information
Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - WALGREENS (008965063) |