Indications and uses
For the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain back pain common cold toothache menstrual cramps Temporarily reduces fever.
PhysiciansCare Extra Stregth Pain Reliever
- Manufacturer
- Acme United Corporation
- Effective date
- 2022-01-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:10:49
Label at a glance#
ProductPhysiciansCare Extra Stregth Pain Reliever
Active ingredientASPIRIN, CAFFEINE, ACETAMINOPHEN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid
Uses
For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- minor arthritis pain
- back pain
- common cold
- toothache
- menstrual cramps
Temporarily reduces fever.
WARNINGS SECTION
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
Caffeine warning: This product contains caffeine. 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
•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
•f you ever have had an allergic reaction to any other pain relievers/ fever reducers
right before or after heart surgery
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 a history of stomach problems such as heartburn
- you have asthma
Ask a doctor or pharmacist before use if you are
•taking the blood thinning drug warfarin
•taking a prescription drug for gout, diabetes, or arthritis
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
- 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
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 do not notice any signs or symptoms.
Directions
- 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
- read all product information before using
- store at room temperature 59°-86°F (15°-30°C)
- avoid excessive heat and humidity
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive ingredients
hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide
Questions or comments?
1-800-835-2263
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47682-228-13 | EA - Each | 47682-228 | 20ec9c8d-ab39-43d1-baca-c844b0d07268 | 1 | 2012-07-24 |
| 47682-228-33 | EA - Each | 47682-228 | d17dd275-6ffb-4f53-a585-1502520cffe3 | 1 | 2012-07-24 |
| 47682-228-47 | EA - Each | 47682-228 | eba5432e-920e-4623-b99f-92fa7bcbfcbe | 1 | 2012-07-24 |
| 47682-228-64 | EA - Each | 47682-228 | 2f22a705-ce2f-4523-a25c-8ffeca7ef8d0 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- PhysiciansCare Extra Stregth Pain Reliever
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- STARCH, CORN
- STEARIC ACID
- TITANIUM DIOXIDE
- MALTODEXTRIN
- HYPROMELLOSES
- CELLULOSE, MICROCRYSTALLINE
- SODIUM STARCH GLYCOLATE TYPE A CORN
- ASPIRIN
- CAFFEINE
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0924-0129 | 0924-0129-01 |
| 47682-228 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d6e7f16e-b0fe-8a47-e053-2a95a90a771b | d6e7f5c4-0ffb-b02e-e053-2995a90ad219 | 2022-01-31 | Warnings | d6e7f16e-b0fe-8a47-e053-2a95a90a771b d6e7f5c4-0ffb-b02e-e053-2995a90ad219 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.