FDA Label for Pharbinex-dm
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- 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.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pharbinex-dm Product Label
The following document was submitted to the FDA by the labeler of this product Pharbest Pharmaceuticals, 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 Ingredients (In Each Tablet)
Guaifenesin 400mg
Dextromethorphan HBr 20mg
Purpose
Expectorant
Cough suppressant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- helps make cough more productive
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.
Ask A Doctor Before Use If You Have
- persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occure with fever, rash or persistent headache
These could be signs of serious illness.
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 (1-800-222-1222).
Directions
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- do not exceed 6 doses in 24 hours or as directed by doctor
adults and children 12 years of age and over | take 1 tablet every 4 hours as needed |
children 6 to under 12 years of age | take ½ tablet every 4 hours as needed |
children under 6 years of age | consult a doctor |
Other Information
- store at room temperature (15°-30°C)
Inactive Ingredients
magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.
Questions?
Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM
Package Label.Principal Display Panel
PHARBEST
NDC 16103-381-04
Manufactured in the USA
Immediate Release
*Compare to the active ingredient in MUCINEX® DM Tablets
PHARBINEX-DM
Guaifenesin 400mg & Dextromethorphan HBr 20mg
Expectorant & Cough Suppressant
30 TABLETS
* Please review the disclaimer below.