Active Ingredient
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Pain Terminator (NDC 84269-2533). 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 ingredient, purpose, indications & usage, warnings, other, do not use, ask doctor, ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid
Uses
temporarily relieves minor aches and pains due to
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:
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:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
Stop use and ask a doctor if
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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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.
Directions
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 information
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc
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