Checked
OTC
Extra Strength Pain Aid
acetaminophen, aspirin, caffeine · Extra Strength Pain Aid is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin, caffeine, made by Hi-Tech Nutaceuticals, LLC.
- Type
- Over the counter
- Drug class
- Central Nervous System Stimulant
- Route
- Oral
- Manufacturers
- 1
Drug facts
- Generic name
- acetaminophen, aspirin, 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
- Label holder
- Hi-Tech Nutaceuticals, LLC
- FDA application
- M013
- Label updated
- 07/06/2026
Active ingredients
Actives
Warnings
More warnings
Ask a doctor before use
Ask a doc
Ask a doctor or pharmacist before use
Ask a doc or pharm
When using this product
When using
Stop use and ask a doctor
Stop Use
Pregnancy or breastfeeding
Pregnant
Keep out of reach of children
Keep out of reach
Other information
Storage
Inactive ingredients
Inactives
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 65 mg / 250 mg / 250 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- Hi-Tech Nutaceuticals, LLCShown hereM013 · Label 07/06/2026 · NDC 69732-006Full 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 Strength Pain Aid: common questions
- Is Extra Strength Pain Aid a prescription drug?
- No. Extra Strength Pain Aid is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Extra Strength Pain Aid?
- 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 Strength Pain Aid?
- Hi-Tech Nutaceuticals, LLC lists Extra Strength Pain Aid with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/06/2026 · Label text is shown as published by the manufacturer. Not medical advice