FDA Label for Only For Headache

Drug Facts

Active Ingredient (In Each Geltab)

Acetaminophen 250mg

Aspirin 250mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses:

Temporarily relieves minor aches and pains due to:

• headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Warnings:

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flue-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 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 geltabs 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) • 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 this product contains about a much caffeine as 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 • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma

Ask a doctor or pharmacist before use if you are taking

• a prescription drug for diabetes, gout, or arthritis

• any other drug, or are under a doctor's care for any serious condition

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 • ringing in the ears or loss of hearing occurs • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding, ask a health 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 compliments during delivery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case overdose. get medical help or contact a Poison Control Center right away.

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 geltabs every 6 hours; not more than 8 geltabs in 24 hours

• children under 12 years: ask a doctor

Other Information:

• store at room temperature between 20-25°C (68 to 77°F) • avoid excessive heat, cold and humidity • close cap tightly after use • read all product information before using.

Inactive Ingredients:

ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No.10 lake, ethyl cellulose, FD&C blue No.1 lake, FD&C red No.40 lake, gelatin, glycerin, hydroxypropyl methyl cellulose, isopropyl alcohol, isopropyl alcohol - butyl alcohol, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, polysorb 85/70/00, povidone K30, pregelatinised starch, propylene glycol, purified water, shellac glaze, stearic acid, talc, titanium dioxide, triacetin

Questions Or Comments?

1-833-665-9444. (Mon-Fri 9am-5pm)

Packaging

IMAGE - 7300613295