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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 Relief Pm (NDC 50405-007). 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, liver warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur if you take
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.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out or reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. 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.
| adults and children 12 years and over |
|
| children under 12 years | do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. |
carnauba wax, FD&C blue #1 aluminium lake, FD&C blue #2 aluminium lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium citrate, sodium starch glycolate, titanium dioxide
Contains No Aspirin
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