FDA Label for Xpecto Soothing Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 10 ML)
- PURPOSES
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL
Xpecto Soothing Relief Product Label
The following document was submitted to the FDA by the labeler of this product Midway Importing Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 10 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg
Purposes
Cough suppressant
Expectorant
Nasal Decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occurring with a cold
- nasal congestion
- cough due to minor throat and bronchial irritation
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
- trouble urinating due to enlarged prostate gland
- high blood pressure
- thyroid disease • heart disease • diabetes
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other oral nasal decongestant or stimulant
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, 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
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product mL=milliliter
- this adult product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10mL every 4 hours
- children under 12 years: do not use
Other Information
- store at 20C-25C (68F-77F). Do not refrigerate
Inactive Ingredients
anhydrous citric acid,FD&C Red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Questions Or Comments?
Call 703-802-9363
Package Label
* Please review the disclaimer below.