49483-234 Pseudo Time Pe

49483-234 Pseudo Time Pe
SPL v2
SPL
SPL Set ID 3116f273-0517-4755-95cd-be3a7c0dd76b
Route
ORAL
Published
Effective Date 2012-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Magnesium Silicate Cellulose, Microcrystalline Polyethylene Glycol 400 Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T234 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-05-14
Description

Each tablet contains: Phenylephrine HCl 10 mg

Medication Information

Warnings and Precautions

WARNINGS;

Do not use if you are 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.

Indications and Usage

Uses:

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis

Temporarily relieves sinus congestion and pressure

Dosage and Administration

DIRECTIONS:

Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet

Children under 12 years of age; ask a doctor



Description

Each tablet contains: Phenylephrine HCl 10 mg

Section 50565-1

keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6
INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

Section 51945-4

Section 55105-1
PURPOSE: nasal decongestant

Section 55106-9
Each tablet contains: Phenylephrine HCl 10 mg

Structured Label Content

Indications and Usage (34067-9)

Uses:

Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis

Temporarily relieves sinus congestion and pressure

Dosage and Administration (34068-7)

DIRECTIONS:

Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet

Children under 12 years of age; ask a doctor



Warnings and Precautions (34071-1)

WARNINGS;

Do not use if you are 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 50565-1 (50565-1)

keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)
INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
PURPOSE: nasal decongestant

Section 55106-9 (55106-9)
Each tablet contains: Phenylephrine HCl 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:42.570254 · Updated: 2026-03-14T22:55:22.018235