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NDC 63868-0411-20 Naproxen PM 25; 220 mg/1; mg/1 Details

Naproxen PM 25; 220 mg/1; mg/1

Naproxen PM is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM.

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: 63868-0411-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 63868-0411-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	63868-0411
Product ID	63868-411_cda83d4d-e630-4708-aafd-495681a3f2b7
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	Naproxen PM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25; 220
Active Ingredient Units	mg/1; mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA209726
Listing Certified Through	n/a

Package

NDC 63868-0411-20 (63868041120)

Pricing Information	N/A
NDC Package Code	63868-411-20
Billing NDC	63868041120
Package	1 BOTTLE, PLASTIC in 1 BOX (63868-411-20) / 20 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	2019-01-31
NDC Exclude Flag	N