Active Ingredients
Each 7.5 mL. Contains (1 1/2 tsp)
Dextromethorphan HBr 15 mg......Antitussive
Glyceryl Guaiacolate 150 mg....Expectorant
Sorbutuss Liquid
FDA Label NDC 68436-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Sorbutuss (NDC 68436-120). 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, purpose section, these highlights do not include all the information needed to use sorbutuss. see full prescribing information for initial u.s. approval, warnings, ask a doctor before use if you have, stop use and ask a doctor if, pregnancy or breast feeding section, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose Section
Antitusive
Expectorant
These Highlights Do Not Include All The Information Needed To Use Sorbutuss. See Full Prescribing Information For Initial U.S. Approval
- For the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold.
- Helps loosen phlegm (mucus) and thin bronchial secretions to makes cough 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
- Chronic cough that last such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- Cough that occurs with too much phlegm (mucus).
Stop Use And Ask A Doctor If
- Cough last for more than 7 days comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use
Keep Out Of Reach Of Children
In a case of overdose, get medical help or contact a Poison Control Center right away.
These Highlights Do Not Include All The Information Needed To Use
Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period.
Adults and children 12 years and older 2 teaspoonfuls every 4 hours
Children 6 years to under 6 years 1 teaspoonful every 4 hours
Children 2 years to 6 years 1/2 teaspoonful every 4 hours
Children under 2 years Consult a doctor
Other Information
Store at room temperature 15°-30° C (59° - 86° F)
Inactive Ingredients
Artificial and Natural Flavors, Glycerin, Methylparaben, Potassium Citrate, Propylparaben, Purified Water, Sorbitol and Sucralose
Questions Or Comments?
Teral, Inc. (787) 383-2781 Fax (787) 284-9082
Safety Information
Do not accept if safety seal around bottle cap is broken or missing
Expiration Date Information
Lot:
Exp:
Rev:12/06
Principal Panel
NDC 68436-120-16
Sorbutuss NR
Antitussive-Expectorant
Does Not Containt
Antihistamines
Decongestants
Sodium
With
Sucralose
Sugar Free Alcohol Free
Dye Free
Grape Flavor
16 oz. fl. oz. (474 mL)
Manufacture for
Teral, Inc.
Ponce, P.R. 00731
* Please review the disclaimer below.
