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  5. Label Information: Dexbrompheniramine Maleate And Phenylephrine Hydrochloride

FDA Label for Dexbrompheniramine Maleate And Phenylephrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 60 TABLET BOTTLE LABEL

Dexbrompheniramine Maleate And Phenylephrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, 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.

Other



DRUG FACTS


Otc - Purpose



Active ingredients (in each tablet)Purpose
Dexbrompheniramine Maleate 2 mgAntihistamine
Phenylephrine HCL 10 mgNasal Decongestant

Uses



Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings



Do not exceed recommended dosage.


Do Not Use This Product



  • 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



  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlargment of the prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.


When Using This Product



  • excitability may occur, especially in children
  • may cause drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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.

Adults and children 12 years of age and over:1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours or as directed by doctor.
Children 6 to under 12 years of age:1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours or as directed by doctor.
Children under 6 years of age:Consult a doctor.

Other Information



Store at 15°-30°C (59°-86°F). Supplied in a tight, light resistant container with a child-resistant cap. Dexbrompheniramine Maleate and Phenylephrine HCl tablets are purple, oval shaped, scored tablets, debossed "WP" bisect "197" on one side and plain on the other.


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C Red #27, dibasic calcium phosphate dihydrate, FD&C Blue #1, magnesium stearate, and microcrystalline cellulose.


Questions? Comments?



Call 1-844-221-7294


Principal Display Panel - 60 Tablet Bottle Label



NDC 69367-197-60

Dexbrompheniramine Maleate
and Phenylephrine HCl

Antihistamine • Nasal Decongestant

Each tablet contains:
Dexbrompheniramine Maleate
2 mg

Phenylephrine HCI
10 mg

60 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label - dexbrom 01

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label - dexbrom 01


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