Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameNAPROXEN SODIUM
Labeler / manufacturerBryant Ranch Prepack
RouteORAL
Drug classDrug class not supplied in source label
Product NDC71335-3009
Label effective date2026-02-04
Official product label reference
Rugby All Day Relief — Bryant Ranch Prepack
This page contains 16 source sections for NAPROXEN SODIUM, oral route. Label set 3238dfdc-82d1-4afb-b27c-0ba0a5d24744, version 1.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever
Purpose
Purposes Pain reliever/fever reducer
Dosage and administration — label text
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 • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period Children under 12 years • ask a doctor
Table text from source:
| Adults and children 12 years and older | •take 1 caplet every 8 to 12 hours while symptoms last•for the first dose you may take 2 caplets within the first hour•do not exceed 2 caplets in any 8- to 12-hour period•do not exceed 3 caplets in a 24-hour period
| Children under 12 years | •ask a doctor
Warnings
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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Active ingredient
Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Do not use
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
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
Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • taking any other drug
While using this medicine
When using this product • take with food or milk if stomach upset occurs
When to stop use and seek help
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
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Storage and handling
Other information • each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredient
Inactive ingredients FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions
Questions or comments? 1-800-719-9260
Supply and packaging
HOW SUPPLIED Naproxen Sodium 220mg Tablets Nonsteroidal Anti-Inflammatory Drug (NSAID) NDC 71335-3009-1: 20 Tablets in a BOTTLE NDC 71335-3009-2: 30 Tablets in a BOTTLE NDC 71335-3009-3: 40 Tablets in a BOTTLE NDC 71335-3009-4: 50 Tablets in a BOTTLE NDC 71335-3009-5: 60 Tablets in a BOTTLE NDC 71335-3009-6: 14 Tablets in a BOTTLE NDC 71335-3009-7: 100 Tablets in a BOTTLE NDC 71335-3009-8: 90 Tablets in a BOTTLE NDC 71335-3009-9: 24 Tablets in a BOTTLE store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.