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NDC 62011-0396-01 Naproxen Sodium PM 25; 220 mg/1; mg/1 Details
Naproxen Sodium PM 25; 220 mg/1; mg/1
Naproxen Sodium PM is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 62011-0396-01Last 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: 62011-0396-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Naproxen
Product Information
| NDC | 62011-0396 |
|---|---|
| Product ID | 62011-0396_2f5ffa22-168c-43c9-b5fe-7e93f6c2aa1a |
| Associated GPIs | |
| GCN Sequence Number | 073286 |
| GCN Sequence Number Description | naproxen sod/diphenhydramine TABLET 220MG-25MG ORAL |
| HIC3 | S2S |
| HIC3 Description | ANALGESIC,NSAID-1ST GEN.ANTIHISTAMINE,SEDATIVE CMB |
| GCN | 37667 |
| HICL Sequence Number | 041669 |
| HICL Sequence Number Description | NAPROXEN SODIUM/DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Naproxen Sodium 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 | Strategic Sourcing Services LLC |
| 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 | 2024-12-31 |
Package
Package Images
NDC 62011-0396-01 (62011039601)
| NDC Package Code | 62011-0396-1 |
|---|---|
| Billing NDC | 62011039601 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (62011-0396-1) / 20 TABLET in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2019-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba Details
Active ingredient (in each caplet)
Uses
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- unless you have time for a full night's sleep
- in children under 12 years of age
- right before or after heart surgery
- with any other product containing diphenhydramine, even one used on skin
- if you have sleeplessness without pain
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducer
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you have a breathing such as emphysema or chronic bronchitis
- you have glaucoma
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- pain gets worse or last more than 10 days
- sleeplessness persists continuously for more than 2 weeks insomnia may be a symptom of a serious underlying medical illness.
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
If pregnant or breast-feeding,
Keep out of reach of children.
Directions
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Aleve® PM†
Naproxen PM
Naproxen Sodium 220 mg
Pain reliever (NSAID)
Diphenhydramine HCI 25 mg/
Nighttime sleep-aid
COATED CAPLETS**
(**Capsule-shaped tablets)
†This product is not manufactured or distributed by Bayer Health Care, LLC, distributor of Aleve® PM
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INGORMATION.
Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104
healthmart.com
INGREDIENTS AND APPEARANCE
| NAPROXEN SODIUM PM
naproxen sodium tablet |
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| Labeler - Strategic Sourcing Services LLC (116956644) |