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NDC 68210-2100-01 NIGHTTIME SLEEP AID 25 mg/1 Details
NIGHTTIME SLEEP AID 25 mg/1
NIGHTTIME SLEEP AID is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by SPIRIT PHARMACEUTICALS LLC. 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: 68210-2100-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 68210-2100 |
|---|---|
| Product ID | 68210-2100_ee03982b-60b2-e830-e053-2995a90a98ae |
| 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 | NIGHTTIME SLEEP AID |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | SPIRIT PHARMACEUTICALS LLC |
| 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 | 2023-12-31 |
Package
Package Images
NDC 68210-2100-01 (68210210001)
| NDC Package Code | 68210-2100-1 |
|---|---|
| Billing NDC | 68210210001 |
| Package | 1 BLISTER PACK in 1 CARTON (68210-2100-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2020-03-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 462643c0-8813-4635-8edc-42c1f5b26400 Details
Uses
SPL UNCLASSIFIED SECTION
Warnings
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 asthma, emphysema, or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- heart disease
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid
When using this product
- avoid alcoholic beverages and other drugs that cause drowsiness
- drowsiness will occur
- be careful when driving a motor vehicle or operating machinery
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| NIGHTTIME SLEEP AID
diphenhydramine hydrochloride capsule, liquid filled |
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| Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) |