Active Ingredients
(in each powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by 9 Rx Llc for the product Extra Strength Headache Powder (NDC 84800-041). 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 active ingredients, purposes, uses, warnings:, do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Pain reliver aid
temporarily relives minor aches and pains due to:
temporarily reduces fever
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 severe allergic reaction which may include:
• hives • facial swelling • shock • asthma (wheezing).
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Stomach bleeding warning: This product contains a NSAID, which may cause severe stomach bleeding. The chance is higher if you
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis the blood thinning drug warfarin.
feel faint vomit blood have bloody or black stool have stomach pain that does not get better
These could be signs of a serious condition.
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.
Taking more than the recommended dose can cause serious health problems. 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.
lactose monohydrate, potassium chloride
* Please review the disclaimer below.