Label: FIRST AID DIRECT ALL DAY PAIN RELIEF- naproxen sodium tablet, coated
- NDC Code(s): 42961-122-01, 42961-122-02
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 19, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- skin reddening
- shock
- blisters
- rash
- facial swelling
- hives
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 nonsprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
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 are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- 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
Stop use and ask 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 • slurred speech • trouble breathing • weakness in one part or side of body
- 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
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DOSAGE & ADMINISTRATION
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 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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Outer Package Label
ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, 220 mg
Pain Reliever/Fever Reducer (NSAID)
- Helps to temporarily relieve: backaches, headaches, minor pain of arthritis, muscular aches, menstrual cramps
Compare to the active ingredient in Aleve®†
Manufactured for: fad first aid direct® Mason, OH 45040
25 Tablets • 1 Tablet per Packet
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INGREDIENTS AND APPEARANCE
FIRST AID DIRECT ALL DAY PAIN RELIEF
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-122 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 7mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-122-02 25 in 1 BOX 07/19/2023 1 NDC:42961-122-01 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 07/19/2023 Labeler - Cintas Corporation (056481716) Registrant - Cintas Corporation (056481716)