Otc - Active Ingredient
Active ingredients
(in each caplets)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Agrifen (NDC 69729-159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
(in each caplets)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg ........Pain reliever
Aspirin 250 mg (NSAID)*........Pain reliever
Caffeine 65 mg.......................Pain reliever aid
*nonsteroidal anti-inflammatory drug
temporarily relieves minor aches and pains due to:
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.
Aspirin may cause a severe allergic reaction, which may include:
This product contains acetaminophen. Severe liver damage may occur if you take:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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 complications during delivery.
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.
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Read & Keep Outer Carton for Complete Product Information
NDC 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
* Please review the disclaimer below.