Otc - Purpose
Purpose
Dexbrompheniramine Maleate .................. Antihistamine
Pseudoephedrine HCI ................... Nasal Decongestant
Durahist Tablet
FDA Label NDC 50991-865
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Durahist (NDC 50991-865). 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, otc - active ingredient, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2mg
Pseudoephedrine HCI 60mg
Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or 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.
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to enlargement 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.
Otc - When Using
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
Otc - Stop Use
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
| Adults and children
12 years of age and over: | 1 tablet every 4 to 6
hours, not to exceed 4 tablets in 24 hours. |
| Children 6 to under
12 years of age: | 1/2 tablet every 4 to 6
hours, not to exceed 2 tablets in 24 hours. |
| 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.
Durahist Tablets are pink caplet shaped, scored tablets, debossed "Poly" bisect "865" on one side and plain on the other.
Inactive Ingredients
Lake Blend Red, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.
Questions?
Call 1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355
Rev. 09/2024
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel for 90 tablets label:
NDC 50991-865-90
Label (Durahist865)
* Please review the disclaimer below.
