Pecgen Dmx Solution
FDA Label NDC 52083-630
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Pecgen Dmx (NDC 52083-630). 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 drug facts, active ingredients (in each 5ml tsp), purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5Ml Tsp)
Dextromethorphan HBr, 10 mg
Guaifenesin, 187 mg
Purpose
Cough Suppressant
Expectorant
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Uses
• suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
• cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product do not use more than directed.
Stop use and ask a doctor if • symptoms do not get better within 7 day or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredients
Citric acid, flavors, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sodium citrate and sucralose
Other Information
• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat or humidity.
Other
Manufactured in the USA for Kramer Novis. San Juan, PR 00917. Tel: (787) 767-2072 / www.kramernovis.com
* Trispec® DMX is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.
* Please review the disclaimer below.
