PHYSICIANS CARE ASPIRIN- aspirin 325mg tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Acme United Corporation
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Temporarily relieves minor aches and pains associated with ■ headache ■ minor arthritis pain ■ common cold ■ menstrual cramps ■ muscular aches ■ backache ■ toothache Temporarily reduces fever. ■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer ■ right before or after heart surgery ■ if you are taking prescription drugs for gout, diabetes or arthritis ■ 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 ■ under a doctor's care for any serious condition ■ taking any other drug ■ 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 ■ you have difficulty swallowing ■ if ringing in
Authorization status:
OTC monograph final
Authorization number:
0924-0104-00, 0924-0104-01, 0924-0104-02, 0924-0104-03, 0924-0104-07

PHYSICIANS CARE ASPIRIN- aspirin 325mg tablet, coated

Acme United Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Physicians Care Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

■ headache

■ minor arthritis pain

■ common cold

■ menstrual cramps

■ muscular aches

■ backache

■ toothache

Temporarily reduces fever.

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

■ skin reddening

■ facial swelling

■ rash

■ asthma (wheezing)

■ blisters

■ 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

■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer

■ right before or after heart surgery

■ if you are taking prescription drugs for gout, diabetes or arthritis

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 a doctor or pharmacist before use if you are

■ under a doctor's care for any serious condition

■ taking any other drug

When using this product

■ take with food or milk if stomach upset occurs

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

■ you have difficulty swallowing

■ if ringing in the ears or loss of hearing occurs

■ 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 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.

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

Directions

do not take more than directed

the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

■ drink a full glass of water with each dose

Adults and children: Take 1 or 2 tablets with water every 4 hours as needed. Do not

(12 years and older) take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Inactive ingredients

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium

dioxide

Other information

■ read all product information before using

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

Questions or comments?

1-800-835-2263

Physicians Care Aspirin

Physicians Care®

Aspirin

Fever Reducer and Pain Reliever

Pull To Open

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Physicians Care®

Registered Trademark of Acme United Corporation

50 Packets (2Tablets 325 Mg Each)

PHYSICIANS CARE ASPIRIN

aspirin 325mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 24-0 10 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MINERAL O IL (UNII: T5L8 T28 FGP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

Acme United Corporation

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

TCL;0 11

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 24-0 10 4-0 3

10 in 1 CARTON

0 2/24/20 15

0 8 /31/20 22

1

NDC:0 9 24-0 10 4-0 0

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 9 24-0 10 4-0 2

125 in 1 CARTON

0 2/24/20 15

0 8 /31/20 22

2

NDC:0 9 24-0 10 4-0 0

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:0 9 24-0 10 4-0 1

50 in 1 CARTON

0 2/24/20 15

0 8 /31/20 22

3

NDC:0 9 24-0 10 4-0 0

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:0 9 24-0 10 4-0 7

25 in 1 CARTON

0 2/24/20 15

0 8 /31/20 22

4

NDC:0 9 24-0 10 4-0 0

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt343

0 2/24/20 15

0 8 /31/20 22

Labeler -

Acme United Corporation (001180207)

Revised: 7/2020

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