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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product All Day Pain Relief (NDC 70005-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, allergy alert:, stomach bleeding warning:, do not use, ask a doctor before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Naproxen Sodium 220 mg | |
| (naproxen 200 mg) (NSAID) * | Pain reliever/fever reducer |
*nonsteroidal anti-inflammatory drug |
■ temporarily relieves minor aches and pains due to:
■ minor pain of arthritis ■ muscular aches ■ backache ■ headache
■ menstrual cramps ■ toothache ■ the common cold
■ temporarily reduces fever
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.
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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
■ 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, or kidney disease
■ you are taking a diuretic
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ you have asthma
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
■ 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
■ 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 during the last 3 months of 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ 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
■ take 1 tablet every 8 to 12 hours while symptoms last 12 years and older
■ 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
■ 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)
FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
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