EligibleTrials

Acetaminophen: clinical trials recruiting now

5
Recruiting trials
6
Conditions studied
4
US states with sites
3
Countries

FDA drug label

FDA-approved
Yes. Acetaminophen appears in the FDA drug-label database. Marketed as Pain Reliever Extra Strength.

FDA-approved use

Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

FDA recalls / enforcement

Reason (FDA)ClassificationStatusInitiated
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. — Perrigo Company PLC Class II (FDA: may cause temporary or reversible harm) Terminated 2021-10-26
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. — Contract Pharmacal Corporation Class II (FDA: may cause temporary or reversible harm) Terminated 2020-02-03
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label. — A-S Medication Solutions LLC. Class I (FDA: reasonable probability of serious harm or death) Terminated 2021-03-02
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenes — Reckitt Benckiser LLC Class I (FDA: reasonable probability of serious harm or death) Terminated 2015-04-15
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. — L. Perrigo Co. Class II (FDA: may cause temporary or reversible harm) Terminated 2013-11-01

FDA label via openFDA

Phase breakdown

Phase 1 4 Phase 2 1 Not applicable 1

Conditions being studied

ConditionTrials
Obesity · Acetaminophen for Obesity3
Overweight · Acetaminophen for Overweight3
Crohn's disease2
Crohn Disease1
Crohn's Disease (CD)1
Dysmenorrhea Primary1

Recruiting trials involving Acetaminophen

Common questions

Is Acetaminophen FDA-approved?

Yes, marketed as Pain Reliever Extra Strength.

How many recruiting trials involve Acetaminophen?

5 recruiting trials across 6 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.

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