A white oblong tablet imprinted with TCL 370 is an over-the-counter (OTC) combination analgesic commonly sold as generic Extra Pain Relief or generic Excedrin Extra Strength / Excedrin Migraine.
Identification
Attribute – Specification
- Active Ingredients – Acetaminophen (250 mg) + Aspirin (250 mg) + Caffeine (65 mg)
- Imprint –
TCL 370 - Color & Shape – White, capsule-shaped / oblong, film-coated tablet
- Size – Approximately 18 mm
- Drug Class – Analgesic combinations (NSAID + non-opioid analgesic + central nervous system stimulant)
- Manufacturer / Packager – Time Cap Laboratories Inc. (TCL)
- Controlled Substance Status – Not a controlled substance (OTC)
Mechanism of Action
The formulation relies on a multimodal, synergistic approach where three active ingredients work together:
- Acetaminophen (250 mg): Primarily acts as a centrally acting analgesic and antipyretic. It inhibits prostaglandin synthesis in the central nervous system (CNS) and elevates the overall pain threshold, helping relieve aches without providing significant anti-inflammatory action.
- Aspirin (250 mg): A nonsteroidal anti-inflammatory drug (NSAID) that irreversibly inhibits cyclooxygenase enzymes (COX-1 and COX-2). This prevents the conversion of arachidonic acid to pro-inflammatory prostaglandins and thromboxanes, providing anti-inflammatory, pain-relieving, and fever-reducing effects.
- Caffeine (65 mg): Serves as an analgesic adjuvant. It is a non-selective adenosine receptor antagonist that causes cerebral vasoconstriction (countering the cranial vasodilation often associated with vascular headaches and migraines). In addition, it enhances gastrointestinal absorption and potentiates the pain-relieving efficacy of both acetaminophen and aspirin by approximately 40%.
Indications and Dosage
Primary Indications:
- Tension headaches and vascular headaches
- Migraines (associated pain, photophobia, phonophobia)
- Minor aches and pains due to arthritis, muscle aches, toothaches, menstrual cramps, or the common cold
Standard Adult Dosage (Ages 12 and older):
- Standard dose: Take 2 caplets orally with a full glass of water every 6 hours as needed while symptoms persist.
- Maximum dose: Do not exceed 8 caplets within a 24-hour period (or no more than 2 caplets in 24 hours if using strictly under specific migraine labeling, unless directed by a physician).
- Children under 12: Do not use unless explicitly directed by a doctor.
Side Effects
Common Side Effects
- Gastrointestinal discomfort: heartburn, nausea, upset stomach, or mild abdominal cramps
- Nervous system / stimulant effects: restlessness, nervousness, jitters, insomnia, or mild tremor (due to caffeine)
- Mild dizziness
Serious Side Effects
- Gastrointestinal bleeding: Coffee-ground emesis, black/tarry stools, severe stomach cramps.
- Severe allergic reactions: Hives, facial swelling, wheezing, or anaphylaxis.
- Hepatotoxicity: Jaundice (yellowing of eyes/skin), dark urine, or extreme fatigue indicative of liver injury.
- Tinnitus: Ringing or buzzing in the ears, which often signals salicylate toxicity (aspirin overdose).
Precautions and Warnings
- Severe Liver Damage (Acetaminophen Warning): Acetaminophen can cause severe or fatal hepatotoxicity. Never exceed 4,000 mg of acetaminophen per day across all sources. Avoid using this medication alongside other products containing acetaminophen (e.g., Tylenol, DayQuil, Percocet).
- Severe Stomach Bleeding (Aspirin Warning): Aspirin belongs to the NSAID class and increases the risk of severe GI ulceration and bleeding. Risk is substantially elevated in patients who are 60 years or older, have a history of stomach ulcers, take anticoagulants/corticosteroids, or consume 3 or more alcoholic drinks daily.
- Reye’s Syndrome: Children and teenagers recovering from viral infections (such as chickenpox or flu-like symptoms) must not take this medication due to the aspirin content, which is strongly linked to Reye’s syndrome – a rare but often fatal neurological and hepatic illness.
- Caffeine Intake: Patients should limit supplemental dietary caffeine (coffee, tea, energy drinks, colas) while taking this product, as excess caffeine can cause tachycardia, palpitations, and elevated anxiety.
- Medication-Overuse Headaches (Rebound Headaches): Frequent or daily use of combination analgesics containing caffeine for more than 2 to 3 days per week can lead to chronic daily rebound headaches.
- Pregnancy Warning: Aspirin is contraindicated in the third trimester of pregnancy (it can cause premature closure of the fetal ductus arteriosus and bleeding complications during delivery). Consult an obstetrician before use during earlier trimesters.