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NDC 69842-0537-11 Diphenhydramine HCl 25 mg/1 Details
Diphenhydramine HCl 25 mg/1
Diphenhydramine HCl is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, 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: 69842-0537-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 69842-0537 |
|---|---|
| Product ID | 69842-537_9090b252-88b4-8521-e053-2995a90a025e |
| 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 HCl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine HCl |
| 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 | CVS Pharmacy, Inc. |
| 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 | 2024-12-31 |
Package
Package Images
NDC 69842-0537-11 (69842053711)
| NDC Package Code | 69842-537-11 |
|---|---|
| Billing NDC | 69842053711 |
| Package | 1 BOTTLE in 1 CARTON (69842-537-11) / 60 CAPSULE in 1 BOTTLE |
| Marketing Start Date | 2018-06-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6dd802ec-fc26-3913-e053-2a91aa0ad05d Details
SPL UNCLASSIFIED SECTION
Do not use
- for children under 12 years of age
- 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 brochitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
Directions
Other Information
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF BLUE
BAND AROUND CAPSULE IS BROKEN OR MISSING
*This product is not manufactured or distributed by Chattem, Inc., owner of the trademarks Unisom® and SleepMinis™.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule |
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| Labeler - CVS Pharmacy, Inc. (062312574) |