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NDC 70000-0590-01 Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine 25 mg/1 Details
Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine 25 mg/1
Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine is a ORAL BAR, CHEWABLE 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: 70000-0590-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 70000-0590 |
|---|---|
| Product ID | 70000-0590_d27d7318-cf0a-3084-e053-2995a90ac079 |
| Associated GPIs | |
| GCN Sequence Number | 082694 |
| GCN Sequence Number Description | diphenhydramine HCl TAB CHEW 25 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 51196 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | BAR, CHEWABLE |
| 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 70000-0590-01 (70000059001)
| NDC Package Code | 70000-0590-1 |
|---|---|
| Billing NDC | 70000059001 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0590-1) / 10 BAR, CHEWABLE in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-12-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c36631f3-7afd-436d-8b8b-bcf9927af7e1 Details
Uses
Warnings
Do not use
- To make 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
Inactive ingredients:
Principal display Panel-25 mg carton label
INGREDIENTS AND APPEARANCE
| ALLERGY RELIEF DIPHENHYDRAMINE HCI, 25 MG ANTIHISTAMINE
diphenhydramine hcl bar, chewable |
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| Labeler - CARDINAL HEALTH (063997360) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| USpharma Ltd | 080664601 | manufacture(70000-0590) , pack(70000-0590) | |