Physicians Care Extra Strength Pain Reliever
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)