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NDC 46122-0707-78 Extra Strength Night Time Pain Relief 500; 25 mg/1; mg/1 Details
Extra Strength Night Time Pain Relief 500; 25 mg/1; mg/1
Extra Strength Night Time Pain Relief is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by AMERISOURCE BERGEN. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 46122-0707-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 46122-0707-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 46122-0707 |
|---|---|
| Product ID | 46122-707_081540c1-317b-7873-e063-6394a90a0738 |
| Associated GPIs | |
| GCN Sequence Number | 003699 |
| GCN Sequence Number Description | acetaminophen/diphenhydramine TABLET 500MG-25MG ORAL |
| HIC3 | B5S |
| HIC3 Description | ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE |
| GCN | 70221 |
| HICL Sequence Number | 001861 |
| HICL Sequence Number Description | ACETAMINOPHEN/DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Extra Strength Night Time Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | AMERISOURCE BERGEN |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M013 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 46122-0707-78 (46122070778)
| NDC Package Code | 46122-707-78 |
|---|---|
| Billing NDC | 46122070778 |
| Package | 100 TABLET, COATED in 1 BOTTLE (46122-707-78) |
| Marketing Start Date | 2022-09-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04706 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | GNP PAIN RLF PM 25-500 MG CPLT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |