Active Ingredients And Purposes
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The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolex Forte (NDC 55758-509). 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 active ingredients and purposes, otc - purpose, drug facts, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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| Active ingredients | Purposes |
| Acetaminophen 250 mg................... | Pain reliever |
| Aspirin 250 mg (NSAID*)................ | Pain reliever |
| Caffeine 65 mg................................. | Pain reliever aid |
* nonsteroidal anti-inflammatory drug
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Temporarily relieves minor aches and pains due to:
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:
Allergy alert: Aspirin (NSAID) may cause severe allergic reactions. Symptoms may include:
Liver warning:This product contains Acetaminophen. Severe liver damage may occur if you take
Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (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 a rapid heartbeat.
These could be signs of a serious condition.
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, water
Pharmadel LLC
New Castle, DE 19720
Questions? +1-866-359-3478
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength
* Please review the disclaimer below.