FDA Label for Handy Solutions Headache Pain Relief

Other

Drug Facts

Otc - Active Ingredient

Active ingredients (in each caplet)

Acetaminophen 250 mg.

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Indications & Usage

Uses

temporarily relieves minor aches and pains due to

■ headache ■ muscular aches ■ arthritis pain ■ a cold
■ toothache ■ premenstrual and menstrual cramps

Warnings

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

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

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

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

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

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

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

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 68°-77°F (20°-25°C)

■ 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

Inactive ingredients

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

Otc - Questions

Questions or comments? 1-800-525-5097