First Aid Direct All Day Pain Relief
1c9384c1-52f8-4482-88fc-5f5b6d770c42
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Medication Information
Warnings and Precautions
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.
Indications and Usage
Uses
- temporarily relieves minor aches and pains due to: • headache • muscular aches • the common cold • toothache • menstrual cramps • backache • minor pain of arthritis
- temporarily reduces fever
Dosage and Administration
- 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
Description
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 50567-7
When using this product
- take with food or milk if stomach upset occurs
Section 50568-5
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
Section 50569-3
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
Section 50570-1
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51727-6
Inactive ingredients
croscarmellose sodium, FD&C Blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Section 53413-1
Questions? 1-800-327-2704 M-F 8AM-5PM
Section 53414-9
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.
Section 55105-1
Purpose
Pain reliever/fever reducer
Section 55106-9
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Section 60561-8
- 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)
- see end flap for expiration date and lot number
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
Structured Label Content
Indications and Usage (34067-9)
Uses
- temporarily relieves minor aches and pains due to: • headache • muscular aches • the common cold • toothache • menstrual cramps • backache • minor pain of arthritis
- temporarily reduces fever
Dosage and Administration (34068-7)
- 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
Warnings and Precautions (34071-1)
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.
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product
- take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51727-6 (51727-6)
Inactive ingredients
croscarmellose sodium, FD&C Blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Section 53413-1 (53413-1)
Questions? 1-800-327-2704 M-F 8AM-5PM
Section 53414-9 (53414-9)
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.
Section 55105-1 (55105-1)
Purpose
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Section 60561-8 (60561-8)
- 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)
- see end flap for expiration date and lot number
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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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:03.788140 · Updated: 2026-03-14T23:10:14.816739