FDA Label for Pharbinex-pe
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - WHEN USING
- 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?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Pharbinex-pe Product Label
The following document was submitted to the FDA by the labeler of this product Ulai Health Llc. 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 Caplet)
Guaifenesin 400mg
Phenylephrine HCl 10mg
Purpose
Expectorant
Nasal decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
- helps to make cough more productive
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to an enlarged prostate gland
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - When Using
When using this product do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occurs
- symptoms do not improve within 7 days, or are accompanied by a fever
- cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache
These could be sings of a 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 the meals
- do not exceed 6 doses in 24 hours or as directed by a doctor
adults and children 12 years of age and over | take 1 caplet every 4 hours as needed |
children 6 to under 12 years of age | take ½ caplet every 4 hours as needed |
children under 6 years of age | ask a doctor |
Other Information
store at 200- 250C (680-770F)
Inactive Ingredients
croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin
Questions Or Comments?
(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)
Other
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
ULAI HEALTH LLC.
Alexandria, VA 22312
Package Label.Principal Display Panel
PHARBEST
NDC 73057-389-04
Manufactured in the USA
Immediate Release
PHARBINEX-PE
Guaifenesin 400mg
Phenylephrine HCl 10mg
Expectorant &
Nasal Decongestant
30 CAPLETS
* Please review the disclaimer below.