Otc - Purpose
| Active ingredient (in each 20 mL) | Purpose |
| Dextromethorphan HBr 20 mg................... | Cough suppressant |
| Guaifenesin 400 mg................................... | Expectorant |
| Phenylephrine HCl 10 mg ………….......… | Nasal decongestant |
Sanatos Turbo Liquid
FDA Label NDC 55758-322
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos Turbo (NDC 55758-322). 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 otc - purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, 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
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritationnasal congestion due to hay fever
- other upper respiratory allergies
- sinus congestion and pressure
- stuffy nose
Do Not Use
- for children under 12 years of age
- 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 two 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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- a cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such occurs with smoking, asthma or emphysema
- trouble urinating due to an enlarged prostate gland
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- a persistent cough or symptoms do not get better within 7 days
- cough comes back, or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed recommended dosage
- use dosage cup
- mL = milliliter
- do not take more than 6 doses in any 24-hour period
| Age | Dose |
| adults & children 12 years and older | 20 mL every 4 hours |
| children under 12 years of age | do not use |
Inactive Ingredients
anhydrous citric acid, dextrose, D&C red # 33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, saccharin sodium, sodium benzoate, sucralose, xanthan gum, water
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadel.com
* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAXTM Severe Congestion & Cough
* Please review the disclaimer below.
