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NDC 70000-0598-01 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 Cardinal Health. 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: 70000-0598-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 70000-0598 |
|---|---|
| Product ID | 70000-0598_e33cbd1d-1849-145a-e053-2995a90aeb50 |
| Associated GPIs | |
| 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 | Cardinal Health |
| 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 70000-0598-01 (70000059801)
| NDC Package Code | 70000-0598-1 |
|---|---|
| Billing NDC | 70000059801 |
| Package | 2 BLISTER PACK in 1 CARTON (70000-0598-1) / 12 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2022-07-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e33cbd1d-1848-145a-e053-2995a90aeb50 Details
Uses
SPL UNCLASSIFIED SECTION
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Directions
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
DO NOT USE IF PRODUCT APPEARS TO BE TAMPERED WITH OR IF BLISTER UNIT IS BROKEN OR TORN. DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING. KEEP THIS BOX FOR IMPORTANT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Product of China.
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
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| Labeler - Cardinal Health (063997360) |