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NDC 68094-0018-61 Diphenhydramine Hydrochloride 25 mg/1 Details
Diphenhydramine Hydrochloride 25 mg/1
Diphenhydramine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Precision Dose, Inc.. 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: 68094-0018-61Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 68094-0018 |
|---|---|
| Product ID | 68094-018_f4d57ff3-eddc-4cac-ab43-1800e4aa6334 |
| Associated GPIs | 41200030100305 |
| GCN Sequence Number | 011594 |
| GCN Sequence Number Description | diphenhydramine HCl TABLET 25 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 46071 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Precision Dose, Inc. |
| 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 68094-0018-61 (68094001861)
| NDC Package Code | 68094-018-61 |
|---|---|
| Billing NDC | 68094001861 |
| Package | 10 BLISTER PACK in 1 CARTON (68094-018-61) / 10 TABLET in 1 BLISTER PACK (68094-018-59) |
| Marketing Start Date | 2019-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03271 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | DIPHENHYDRAMINE 25 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 Details
Uses
Warnings
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
Other information
Inactive ingredients
How Supplied
SPL UNCLASSIFIED SECTION
Distributed by:
Perrigo
Allegan, MI 49010
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
LI1499
Rev. 08/21
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label
Precision Dose™
NDC 68094-018-61
Unit Dose
diphenhydrAMINE HCl
25 mg Tablets
100 Tablets
(10x10)
Each tablet contains:
Diphenhydramine Hydrochloride 25 mg
Calcium 20 mg
Gluten Free
USUAL DOSE: SEE ENCLOSED INSERT.
Store at 20-25°C (68-77°F).
Avoid high humidity. Protect from light.
Keep out of reach of children.
Hospital Use Only.
LC1498
R0
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride tablet |
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| Labeler - Precision Dose, Inc. (035886746) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Precision Dose, Inc. | 035886746 | REPACK(68094-018) | |