Search by Drug Name or NDC
NDC 00113-7901-83 basic care naproxen sodium 200 mg/1 Details
basic care naproxen sodium 200 mg/1
basic care naproxen sodium 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 NAPROXEN SODIUM.
Product Information
| NDC | 00113-7901 |
|---|---|
| Product ID | 0113-7901_ec3997fc-6246-44cf-b835-d1207c43fec5 |
| 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 | basic care naproxen sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen Sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | NAPROXEN SODIUM |
| Labeler Name | L. Perrigo Company |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074661 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00113-7901-83 (00113790183)
| NDC Package Code | 0113-7901-83 |
|---|---|
| Billing NDC | 00113790183 |
| Package | 225 TABLET, FILM COATED in 1 BOTTLE (0113-7901-83) |
| Marketing Start Date | 2019-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 155792d8-37d0-4a7c-a3d1-b3cd636044dd Details
Active ingredient (in each tablet)
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
- •
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- •
- have 3 or more alcoholic drinks every day while using this product
- •
- 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
- •
- right before or after heart surgery
Ask a doctor before use if
- •
- the stomach bleeding warning applies to you
- •
- 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 problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- •
- under a doctor’s care for any serious condition
- •
- taking any other drug
Stop use and ask a doctor if
- •
- you experience any of the following signs of stomach bleeding:
- •
- feel faint
- •
- vomit blood
- •
- have bloody or black stools
- •
- 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 lasts more than 10 days
- •
- fever gets worse or lasts more than 3 days
- •
- you have difficulty swallowing
- •
- it feels like the pill is stuck in your throat
- •
- redness or swelling is present in the painful area
- •
- any new symptoms appear
Keep out of reach of children.
Directions
- •
- do not take more than directed
- •
- the smallest effective dose should be used
- •
- drink a full glass of water with each dose
|
Adults and children 12 years and older |
|
|
Children under 12 years |
|
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| BASIC CARE NAPROXEN SODIUM
naproxen sodium tablet, film coated |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - L. Perrigo Company (006013346) |
Revised: 5/2019
Document Id: ec3997fc-6246-44cf-b835-d1207c43fec5
Set id: 155792d8-37d0-4a7c-a3d1-b3cd636044dd
Version: 2
Effective Time: 20190509