FIRST AID DIRECT ALL DAY PAIN RELIEF- naproxen sodium tablet, coated

First Aid Direct All Day Pain Relief by

Drug Labeling and Warnings

First Aid Direct All Day Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & 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

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

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.

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

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

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, FD&C Blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

QUESTIONS

Questions? 1-800-327-2704 M-F 8AM-5PM

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

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT ALL DAY PAIN RELIEF 
naproxen sodium tablet, coated

Product 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)