DIRECT SAFETY ASPIRIN- aspirin tablet, coated DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

Direct Safety Aspirin by

Drug Labeling and Warnings

Direct Safety Aspirin by is a Otc medication manufactured, distributed, or labeled by Direct Safety, Unifirst First Aid Corporation, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

temporarily relieves

■ headache

■ muscle pain

■ toothache

■ menstrual pain

■ pain and fever of colds

■ minor pain of arthritis

WARNINGS

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

■ hives

■ facial swelling

■ asthma (wheezing)

■ shock

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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

■ have 3 or more alcohol drinks every day while using this product

■ take more or for a longer time than directed

DO NOT USE

Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer

ASK DOCTOR

Ask a doctor before use if

■ 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 asthma

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

STOP USE

Stop use and ask a doctor if

■ an allergic reaction occurs. Seek medical help right away.

■ 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 lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to
exceed 12 tablets in 24 hours

Children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

I nactive ingredients

corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

* may contain

QUESTIONS

Questions or comments? 1-800-356-9100

PRINCIPAL DISPLAY PANEL

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

PRINCIPAL DISPLAY PANEL

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)

INGREDIENTS AND APPEARANCE

DIRECT SAFETY ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61245-620
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FR21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61245-620-13	250 in 1 BOX	02/15/2021	04/01/2024
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/15/2021	04/01/2024

DIRECT SAFETY ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61245-616
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61245-616-13	250 in 1 BOX	02/15/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/15/2021

Labeler - Direct Safety (023316151)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(61245-616, 61245-620)