PHYSICIANS CARE ASPIRIN- aspirin tablet, coated PHYSICIANS CARE ASPIRIN- aspirin tablet, film coated

Physicians Care Aspirin by

Drug Labeling and Warnings

Physicians Care Aspirin by is a Otc medication manufactured, distributed, or labeled by Acme United Corporation, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

Temporarily relieves:

■ headache

■ minor arthritis pain

■ pain & fever of colds

■ backache

■ menstrual cramps

■ toothache

■ muscle aches

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

■ shock

■ asthma (wheezing)

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 asthma

■ 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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

■ taking prescription drugs for gout, diabetes or arthritis

STOP USE

Stop use and ask a 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

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present in the painful area

■ any new symptoms appear

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically 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

■ read all product information before using

■ store at room temperature

■ avoid excessive heat and humidity

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

OTHER SAFETY INFORMATION

Questions or comments? 1-800-835-2263

Physicians Care Aspirin Label

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)

PRINCIPAL DISPLAY PANEL

90014

Physicians Care®

Aspirin

Pain Reliever and fever Reducer (NSAID)

Pull To Open

This Package for Households without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aspirin (NSAID) 325 mg

100 Tablets (50 Packets, 2 tablets each)

INGREDIENTS AND APPEARANCE

PHYSICIANS CARE ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0106
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
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)

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: 0924-0106-01	50 in 1 BOX	04/01/2021	05/31/2023
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-0106-00	2 in 1 PACKET; Type 0: Not a Combination Product	04/01/2021	05/31/2023
3	NDC: 0924-0106-02	125 in 1 BOX	04/01/2021	05/31/2023
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-0106-03	10 in 1 BOX	04/01/2021	05/31/2023
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0924-0106-07	25 in 1 BOX	04/01/2021	05/31/2023
5		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 Drug	M013	04/01/2021	05/31/2023

PHYSICIANS CARE ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0924-0105
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
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0924-0105-01	50 in 1 BOX	07/20/2020
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0924-0105-00	2 in 1 PACKET; Type 0: Not a Combination Product	07/20/2020
3	NDC: 0924-0105-02	125 in 1 BOX	07/20/2020
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0924-0105-03	10 in 1 BOX	07/20/2020
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0924-0105-07	25 in 1 BOX	07/20/2020
5		2 in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 0924-0105-04	6 in 1 CARTON	07/20/2020
6	NDC: 0924-0105-00	2 in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 0924-0105-05	20 in 1 CARTON	07/20/2020
7	NDC: 0924-0105-00	2 in 1 PACKET; Type 0: Not a Combination Product
8	NDC: 0924-0105-06	250 in 1 CARTON	07/20/2020
8	NDC: 0924-0105-00	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 Drug	M013	07/20/2020

Labeler - Acme United Corporation (001180207)

Registrant - Unifirst First Aid Corporation (832947092)