Active Ingredients (In Each 30 Ml)
Choline Salicylate (NSAID)* ... 870 mg
Dextromethorphan HBr ... 20 mg
Guaifenesin ... 200 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Texaclear Severe Cough, Cold And Flu (NDC 58809-217). 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 (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Choline Salicylate (NSAID)* ... 870 mg
Dextromethorphan HBr ... 20 mg
Guaifenesin ... 200 mg
*nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
Cough suppressant
Expectorant
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:Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
ask a health professional before use. It is especially important not to use salicylates (NSAIDs) 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.
| adults and children 12 years of age and over: | 30 mL every 4 hours. |
| children under 12 years of age: | do not use |
citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
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* Please review the disclaimer below.