Physicians Care Extra Strength Pain Reliever

Manufacturer
Acme United Corporation
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:35:49

Label at a glance#

ProductPhysicians Care Extra Strength Pain Reliever
Active ingredientASPIRIN, ACETAMINOPHEN, CAFFEINE
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pauns associated with headache muscular aches minor arthritis pain back pain common cold toothache menstrual cramps Temporarily reduces fever.

Dosage and administration

do not use more than directed Adults and children: (12 years and older) Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pauns associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • back pain
  • common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever.

Warnings

WARNINGS SECTION

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 or allergic 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 4,0000 mg of acetaminophen in 24 hours
  • 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)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning: The recommended dose of th

is 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.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
    acetaminophen, ask a doctor or pharmacist.
  • for pain for more than 10 days unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you ever have had an allergic reaction to any other pain relievers/ fever reducers
  • right before or after heart surgery
  • if you are taking prescription drugs for gout, diabetes, or arthritis

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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 a history of stomach problems such as heartburn
  • you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking a prescription drug for gout, diabetes or arthritis

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • symptoms do not improve
  • 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
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

OTHER SAFETY INFORMATION

  • read all product information before using
  • store at room temperature 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-835-2263

Physicians Care XS Pain Reliever Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

90316

Physicians Care®

Exra Srength

Pain Reliver

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

Pull To Open

This Package For Househlds Without Young Children.

Coated Tablets

Tamper-Evident Packets of 2 Tablets

Do not use if package is open or torn.

100 Tablets (50 Packets, 2 tablets each)

PC XSPC XS

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-01300924-0130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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
f5509ba9-3c95-01fb-e053-2a95a90a82b44dee6551-817d-3aa1-e054-00144ff8d46c2023-02-22WarningsExact identifier
spl id: f5509ba9-3c95-01fb-e053-2a95a90a82b4
spl set id: 4dee6551-817d-3aa1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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