AGRIFEN

Generic name: Acetaminophen, aspirin, caffeine

OPMX LLC

Dosage Form

N/A

Manufacturer

OPMX LLC

Active ingredients

ACETAMINOPHEN250 mg
CAFFEINE65 mg
ASPIRIN250 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves minor aches and pains due to:

headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual and menstrual cramps

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over
take 2 tablets every 6 hours
do not take more than 8 tablets in 24 hours
children under 12 years: ask a doctor

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

69729-159-12

Full prescribing information (for healthcare professionals)

Drug facts

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 may cause a severe allergic reaction, which may include:

hives
shock
facial swelling
asthma (wheezing)

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 8 tablets in 24 hours, wich 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 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 heartbeat.

Other information

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

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Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.

Do not use if…

Ask a doctor before use if…you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away any n…

Ask a doctor or pharmacist before use if…taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition

Stop use and talk to a doctor if…if you 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…

If you take too much (overdose)In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms…

Package labelNDC 69729-159-12 AGRIFEN Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg Desinflama y alivia el dolor de: Fiebre-Cabeza-Dental Relief inflammation and pains of: Fver-Headache-Toothache 12 Caplets