Active Ingredients (In Each Softgel)
| Active Ingredients (in each softgel) | Purpose |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
Tesalon Tesaperlas Severe Cold Max Relief Capsule, Liquid Filled
FDA Label NDC 69729-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Tesalon Tesaperlas Severe Cold Max Relief (NDC 69729-788). 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 softgel), uses, do not use:, ask a doctor before use if you have:, stop use and ask a doctor if:, if pregnant or breast-feeding:, overdose warning:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- helps loosen phlegm (mucus)
- helps thin bronchial secretions to make coughs more productive
Do Not Use:
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´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
Stop Use And Ask A Doctor If:
- cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding:
- ask a health professional before use.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away. Promt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
- Do not take more than directed- See Overdose warning
- Do not use for more than 7 days.
- Do not take more than 6 softgels in 24 hours
Dosage & Administration
| Adults and children 12 years of age & over | Take 1 softgel every 4 hours with a full glass of water while symptoms persist
|
| Children under 12 years of age | Do not use |
Other Information:
- Store at room temperature between 20-25°C (68-77°F)
- Avoid excessive heat and humidity
Inactive Ingredients:
D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.
Questions Or Comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)
Package Label.Principal Display Panel
Tesalon®
Tesaperlas
Adults
Expectorant & Cough Suppressant
Expectorante & Supresor de la Tos
Controls cough
Controla la tos
Thins & loosens mucus
Adelgaza y expulsa las flemas
SOFTGELS
Dextromethorphan HBr 20 mg / Guaifenesin 400 mg
20 Softgels Box
Read & keep package for complete product information
TAMPER EVIDENT; DO NOT USE IS PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
* Please review the disclaimer below.
