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Drug Facts
Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C, Buena Park, CA 90621
The following Structured Product Label (SPL) was submitted to the FDA by Sohm Inc. for the product Sohmed Pain Reliever (NDC 50405-008). 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 other, otc - purpose, uses, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by : Sohm, Inc.
6920 Knott Ave., Suit A-C, Buena Park, CA 90621
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250mg | pain reliever |
| Aspirin 250mg (NSAID) This Product is not manufactured or distributed by Novartis Consumer Healthcare, Inc. Owner of registered trademark Excedrin®. | Pain reliever |
| Caffeine 65mg | pain reliever aid |
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.
Although rare, possible reactions to consumption of acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of the skin. If you are taking this product and develop a rash or other skin reaction, stop taking this product immediately and seek medical attention.
aspirin may cause a severe allergic reaction which may include :
This product contains acetaminophen. Severe liver damage may occur if you take.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
The recommended dose of this product contains about as much as 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.
Ask a doctor or pharmacist before use if you are taking
Keep out of reach of children.
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.
benzoic acid, carnauba wax, FD&C blue#1, hydroxypropylcellulose, Hypromellose,light mineral oil, microcrystalline cellulose, polysorbate 20, Povidone, propylene glycol,simethicone emulsion, Sorbitan monolaurate, stearic acid, titanium dioxide.
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