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Extra Pain Relief
acetaminophen, aspirin and caffeine · Extra Pain Relief is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin and caffeine, made by TIME CAP LABS.
- Type
- Over the counter
- Drug class
- Central Nervous System Stimulant
- Route
- Oral
- Manufacturers
- 1
temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Drug facts
- Generic name
- acetaminophen, aspirin and caffeine
- Active ingredients
- Acetaminophen, Aspirin, Caffeine
- Drug class
- Central Nervous System StimulantMethylxanthineNonsteroidal Anti-inflammatory DrugPlatelet Aggregation Inhibitor
- How it works
- Cyclooxygenase Inhibitors
- Dosage forms
- Tablet, film coated
- Label holder
- TIME CAP LABS
- FDA application
- M013
- Label updated
- 07/11/2025
Active ingredients
(in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever aid
Uses
Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
Directions
DIRECTIOINS Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
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:
- Skin reddening
- Blisters
- Rash If a skin reaction occurs, stop use and seek medical help right away. Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- Hives
- Facial swelling
- Asthma (wheezing)
- Shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- More than 8 caplets in 24 hours, which 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.
Do not use
If you have 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 contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use
If
- You have liver disease
- Stomach bleeding warning applies to you
- You have a history of stomach problems, such as heartburn
- You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- You are taking a diuretic
- You have asthma
Ask a doctor or pharmacist before use
Taking a prescription drug for diabetes, gout, or arthritis any other drug or are under a doctor’s care for any serious condition
Stop use and ask a doctor
- An allergic reaction occurs. Seek medical help right away.
- You experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better
- Ringing in the ears or loss of hearing occurs
- Painful area is red or swollen
- Pain gets worse or lasts for more than 10 days
- Fever gets worse or lasts for more than 3 days
- Any new symptoms occur These could be signs of a serious condition.
Pregnancy or breastfeeding
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 (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.
Inactive ingredients
Carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Questions?
Call 1-877-290-4008
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, film coated | 250 mg / 250 mg / 65 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- TIME CAP LABSShown hereM013 · Label 07/11/2025 · NDC 49483-370Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing01/14/2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster...SpecGx, LLC · 2 products · Failed Tablet/Capsule Specification: There is a potential for the...
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
- Class IIDrugOngoing11/05/2025TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer...Kenvue Brands LLC · Defective Container
- Class IIDrugOngoing09/03/2025Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter...Baxter Healthcare Corporation · Discoloration
- Class IIDrugOngoing06/25/2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry...Aurobindo Pharma USA Inc · cGMP deviations: Due to confirmed consumer complaints received...
Extra Pain Relief: common questions
- What is Extra Pain Relief used for?
- temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps
- Is Extra Pain Relief a prescription drug?
- No. Extra Pain Relief is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Extra Pain Relief?
- Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength.
- Who makes Extra Pain Relief?
- TIME CAP LABS lists Extra Pain Relief with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/11/2025 · Label text is shown as published by the manufacturer. Not medical advice