First Aid Direct All Day Pain Relief — v3

First Aid Direct All Day Pain Relief

9 Views

Version

v3

Effective date

September 22, 2025

Original packager

Yes

Sections captured

17

Identifiers

Document ID
dc86ba45-5462-4c1b-9a65-4bcf25e0e43b
Set ID
1c9384c1-52f8-4482-88fc-5f5b6d770c42
Application numbers
ANDA204872
Product NDCs
42961-122
Package NDCs
42961-122-01, 42961-122-02
Original packager NDCs

Names & Manufacturers

Brand names
First Aid Direct All Day Pain Relief
Generic names
NAPROXEN SODIUM
Manufacturer names
Cintas Corporation
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
NAPROXEN SODIUM
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
849574
UNII
9TN87S3A3C
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

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
Do Not Use (1)

Sequence 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
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients croscarmellose sodium, FD&C Blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other Safety Information (1)

Sequence 1

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) see end flap for expiration date and lot number
Package Label Principal Display Panel (1)

Sequence 1

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 Box_25
Pregnancy Or Breast Feeding (1)

Sequence 1

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.
Purpose (1)

Sequence 1

Purpose Pain reliever/fever reducer
Questions (1)

Sequence 1

Questions? 1-800-327-2704 M-F 8AM-5PM
Spl Product Data Elements (1)

Sequence 1

First Aid Direct All Day Pain Relief Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE TALC TITANIUM DIOXIDE
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 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. 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 When using this product take with food or milk if stomach upset occurs 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 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.
When Using (1)

Sequence 1

When using this product take with food or milk if stomach upset occurs

OpenFDA raw payload

{'application_number': ['ANDA204872'],
 'brand_name': ['First Aid Direct All Day Pain Relief'],
 'generic_name': ['NAPROXEN SODIUM'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corporation'],
 'package_ndc': ['42961-122-01', '42961-122-02'],
 'product_ndc': ['42961-122'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['849574'],
 'spl_id': ['dc86ba45-5462-4c1b-9a65-4bcf25e0e43b'],
 'spl_set_id': ['1c9384c1-52f8-4482-88fc-5f5b6d770c42'],
 'substance_name': ['NAPROXEN SODIUM'],
 'unii': ['9TN87S3A3C']}