Aprodine - DailyMed Details

Aprodine

SPL v3

SPL

SPL Set ID bbc268b8-fa66-4dc5-b935-f77ae39d28c8

Route

ORAL

Published

Effective Date 2024-02-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (60 mg) Triprolidine (2.5 mg)

Inactive Ingredients

Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 287 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-11

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg

Purpose

Nasal decongestant Antihistamine

How Supplied

Product: 50090-7085 NDC: 50090-7085-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Medication Information

Purpose

Nasal decongestant

Antihistamine

How Supplied

Product: 50090-7085

NDC: 50090-7085-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Description

Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion

Directions

do not take more than directed
adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years: do not use

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.

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions Or Comments?

1-800-426-9391

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children
use caution when driving a motor vehicle or operating machinery
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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.

Active Ingredients (in Each Tablet)

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Pseudoephedrine Hcl, Triprolidine Hcl

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion

Purpose

Nasal decongestant

Antihistamine

Directions

do not take more than directed
adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years: do not use

Do Not Use (Do not use)

How Supplied (HOW SUPPLIED)

Product: 50090-7085

NDC: 50090-7085-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

When Using This Product (When using this product)

do not exceed recommended dosage
excitability may occur, especially in children
use caution when driving a motor vehicle or operating machinery
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Pseudoephedrine HCl 60 mg

Triprolidine HCl 2.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Pseudoephedrine Hcl, Triprolidine Hcl (Pseudoephedrine HCl, Triprolidine HCl)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "TRIPROLIDINE", "unii": "2L8T9S52QM", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose itchy, watery eyes nasal congestion sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion", "Purpose": "Nasal decongestant Antihistamine", "Directions": "do not take more than directed adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years: do not use", "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.", "HOW SUPPLIED": "Product: 50090-7085 NDC: 50090-7085-2 24 TABLET, FILM COATED in a BLISTER PACK / 1 in a CARTON", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide", "Questions or comments?": "1-800-426-9391", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "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.", "Active ingredients (in each tablet)": "Pseudoephedrine HCl 60 mg Triprolidine HCl 2.5 mg", "Ask a doctor before use if you have": "high blood pressure heart disease thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.160954 · Updated: 2026-03-14T23:02:34.788055