Durahist - DailyMed Details

Durahist

SPL v3

SPL

SPL Set ID 33d71863-5cac-669f-e063-6394a90a6f21

Route

ORAL

Published

Effective Date 2025-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (60 mg) Dexbrompheniramine (2 mg)

Inactive Ingredients

Fd&c Red No. 40 Aluminum Lake Cellulose, Microcrystalline Sodium Starch Glycolate Type A Magnesium Stearate Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance

Imprint: Poly;865 Shape: oval Color: pink Size: 11 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Purpose Dexbrompheniramine Maleate .................. Antihistamine Pseudoephedrine HCI ................... Nasal Decongestant

Medication Information

Warnings and Precautions

Do not exceed recommended dosage.

Description

Purpose Dexbrompheniramine Maleate .................. Antihistamine Pseudoephedrine HCI ................... Nasal Decongestant

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

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

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

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 53414-9

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

Section 55105-1

Purpose

Dexbrompheniramine Maleate .................. Antihistamine

Pseudoephedrine HCI ................... Nasal Decongestant

Section 55106-9

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2mg

Pseudoephedrine HCI 60mg

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.

Questions?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 09/2024

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.

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel for 90 tablets label:

NDC 50991-865-90

Inactive Ingredients

Lake Blend Red, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

Structured Label Content

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 and Precautions (34071-1)

Do not exceed recommended dosage.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Dexbrompheniramine Maleate .................. Antihistamine

Pseudoephedrine HCI ................... Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2mg

Pseudoephedrine HCI 60mg

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.

Questions?

Call 1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 09/2024

Other Information (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.

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel for 90 tablets label:

NDC 50991-865-90

Inactive Ingredients (Inactive ingredients)

Lake Blend Red, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40 ALUMINUM LAKE", "unii": "6T47AS764T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXBROMPHENIRAMINE", "unii": "75T64B71RP", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "34071-1": "Do not exceed recommended dosage.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever", "50567-7": "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.", "50569-3": "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", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Dexbrompheniramine Maleate .................. Antihistamine Pseudoephedrine HCI ................... Nasal Decongestant", "55106-9": "Active ingredients (in each tablet) Dexbrompheniramine Maleate 2mg Pseudoephedrine HCI 60mg", "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.", "Questions?": "Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 Rev. 09/2024", "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.", "Product Packaging": "The packaging below represents the labeling currently used. Principal display panel for 90 tablets label: NDC 50991-865-90", "Inactive ingredients": "Lake Blend Red, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:56.472667 · Updated: 2026-03-14T23:11:59.437858