Active Ingredients And Purpose
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Naproxen Pain Relief
- Manufacturer
- Rebel Distributors Corp
- Effective date
- 2011-02-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:27:33
Key Label Information
Uses
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
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
Directions And Dosage
Directions
do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor
Other Label Information
Other information
each tablet contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Label Images
Products
- Naproxen Pain Relief
- NAPROXEN
NDC Codes
Ingredients
Complete SPL Sections
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
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
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
Directions
do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor
Other information
each tablet contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/456815fd-1e98-43fa-8f20-47cc3b8a15bd/456815fd-1e98-43fa-8f20-47cc3b8a15bd.xml
- XML SHA-256
- 1b24b2a198796fe9bf8018f39eb5a8b4df1d7185def0592927a60c7ed23d1ed6
- XML bytes
- 28408
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 456815fd-1e98-43fa-8f20-47cc3b8a15bd-01.jpg | 2011-03-28 |
| otc | 456815fd-1e98-43fa-8f20-47cc3b8a15bd.xml | 2011-03-28 |