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NDC 00113-0431-78 good sense nighttime sleep aid 25 mg/1 Details
good sense nighttime sleep aid 25 mg/1
good sense nighttime sleep aid is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0431-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 00113-0431 |
|---|---|
| Product ID | 0113-0431_a20fd99d-d764-4152-a503-d5a4562a1196 |
| Associated GPIs | 60300020100305 |
| GCN Sequence Number | 003705 |
| GCN Sequence Number Description | diphenhydramine HCl TABLET 25 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 27481 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | good sense nighttime sleep aid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | L. Perrigo Company |
| 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 00113-0431-78 (00113043178)
| NDC Package Code | 0113-0431-78 |
|---|---|
| Billing NDC | 00113043178 |
| Package | 1 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-12-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ba2adc30-0301-4d53-bce6-fc8b7e34b076 Details
Warnings
Do not use
- •
- in children under 12 years of age
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- 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
When using this product
- •
- avoid alcoholic drinks
- •
- drowsiness may occur
- •
- do not drive a motor vehicle or operate machinery
Directions
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| GOOD SENSE NIGHTTIME SLEEP AID
diphenhydramine hydrochloride tablet, film coated |
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| Labeler - L. Perrigo Company (006013346) |