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NDC 61919-0079-30 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 Direct Rx. 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: 61919-0079-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 61919-0079 |
|---|---|
| Product ID | 61919-079_b9469dad-3958-2e41-e053-2a95a90abd26 |
| Associated GPIs | 41200030100110 |
| 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 | Direct Rx |
| 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 | 2023-12-31 |
Package
Package Images
NDC 61919-0079-30 (61919007930)
| NDC Package Code | 61919-079-30 |
|---|---|
| Billing NDC | 61919007930 |
| Package | 30 CAPSULE in 1 BOTTLE (61919-079-30) |
| Marketing Start Date | 2015-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ed1a0488-4300-4372-b254-698ec6bc2db0 Details
Uses
WARNINGS
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get very drowsy
- avoid alcoholic drink
- salcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
DIRECTIONS
- adults and children 12 years and over:take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 15-30 °C (59-86 °F)
- protect from moisture
- For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
Inactive Ingredients
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate
Questions or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.
OTHER INFORMATION
OTHER INFORMATION
Questions or Comments
INGREDIENTS AND APPEARANCE
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
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| BANOPHEN DIPHENHYDRAMINE HCL
diphenhydramine hydrochloride capsule |
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| Labeler - Direct Rx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Direct Rx | 079254320 | repack(61919-079, 61919-174) , relabel(61919-079) | |