Physicians Care Extra Strength Pain Reliever

Manufacturer
Acme United | UniFirst First Aid Corporation
Effective date
2024-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:14:14

Label at a glance#

ProductPhysicians Care Extra Strength Pain Reliever
Active ingredientCAFFEINE, ACETAMINOPHEN, ASPIRIN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 250 mg.

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to

■ headache ■ muscular aches ■ arthritis pain ■ a cold

■ toothache ■ premenstrual and menstrual cramps

WARNINGS SECTION

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 (NSAIDs) may cause a severe allergic reaction which may include:

■ hives ■ facial swelling ■ asthma (wheezing) ■ shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 8 caplets in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

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)

■ take more or for a longer time than directed

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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat

OTC - DO NOT USE SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a

drug contains acetaminophen, ask a doctor or pharmacist.

■ if you ever have had an allergic reaction to any other pain relievers/ fever reducers

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

■ you have asthma

■ you have a history of stomach problems such as heartburn

■ you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for gout, diabetes, or arthritis

■ taking any other drug, or under a doctor’s care for any serious condition

OTC - STOP USE SECTION

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 gets worse or lasts more than 3 days

■ ringing in the ears or loss of hearing occurs

■ painful area is red or swollen

■ any new symptoms appear

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

right away.Prompt medical attention is critical for adults as well as for children even if you do not notice any

signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

Adults and children: (12 years and older) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ read all product information before using

■ store at room temperature 68º-77ºF (20º-25ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets, do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

OTC - QUESTIONS SECTION

Questions or comments? 1-800-835-2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90316

Physicians Care®

Extra Strength Pain Reliever

Acetaminophen. Aspirin (NSAID), and Caffeine

Pain Reliever / Pain Reliever Aid

Pull To Open

Coated Caplets

Tamper-Evident Packets of 2 Caplets

Do not use if packet is open or torn.

100 Caplets (50 Packets, 2 caplets each)

PC XSPC XS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-01310924-0131-00, 0924-0131-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26b9d0d2-ec91-2802-e063-6394a90a070dc3dc51a5-7ac8-07d6-e053-2995a90a67ef2024-11-12WarningsExact identifier
spl set id: c3dc51a5-7ac8-07d6-e053-2995a90a67ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.