Handy Solutions Headache & Pain Relief
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: 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.
Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
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 acetaminophen, aspirin or 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 a history of stomach problems such as heartburn
■ you have asthma
■ 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 professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically 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. Quick 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 over) 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. Keep box for important information.
■ 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
■ each caplet contains: Magnesium 0.58 mg
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? 1-800-525-5097