Otc - Active Ingredient
| Active ingredients (in each Caplet) | |
|---|---|
Acetaminophen 250 mg | |
Aspirin 250 mg (NSAID*) | |
Caffeine 65 mg |
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc. for the product Drx Choice (NDC 68163-066). 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 otc - active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking, stop use and ask a doctor if, 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 250 mg (NSAID*) | |
Caffeine 65 mg |
Pain Reliever
Pain Reliever
Pain Reliever Aid
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 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.
These could be signs of a serious condition.
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.
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.
Colloidal silicon dioxide, Hypromellose, microcrystalline cellulose, , polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc
1-866-467-2748
*Compare to the active ingredients in Excedrin® Extra Strength Headache Caplets
NDC – 68163-066-24
DRx Choice®
Extra Strength
Headache Relief
Acetaminophen 250mg, Aspirin 250mg (NSAID) and Caffeine 65 mg
Pain Reliver/Pain Reliver Aid
24 Caplets
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.
IMPORTANT: Keep this carton for future reference on full labeling.
*This product is not manufactured or distributed by Haleon CH Sarl., owner of registered trademark Excedrin Headache.
* Please review the disclaimer below.