Unishield Sinus Decongestant

Unishield Sinus Decongestant
SPL v5
SPL
SPL Set ID b8f68d9d-2d38-414a-e053-2a95a90a15ec
Route
ORAL
Published
Effective Date 2021-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Titanium Dioxide Propylene Glycol Croscarmellose Sodium Fd&c Red No. 40 Hypromelloses Polyethylene Glycol, Unspecified Silicon Dioxide Fd&c Yellow No. 6 Lactose, Unspecified Form Cellulose, Microcrystalline Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 272 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01
Description

DRug Factr

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Dosage and Administration

Directions

■ do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

Children under 12 years: Ask a doctor

Description

DRug Factr

Section 42229-5

DRug Factr

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless

■ symptoms do not improve within 7 days or are accompanied by fever

Section 50567-7

When using this product

■ do not exceed recommended dosage

Section 50569-3

Ask a doctor before use if you have

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

Section 50570-1

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.

Section 51727-6

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Section 53413-1

Questions or comments? 800-480-5855

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Section 55106-9

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Section 60561-8

Other information

■ store at room temperature 59º-86º F (15º-30º C)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Unishield Sinus Decongestant Label

Unishield

Sinus Decongestant

Phenylephrine HCl 10 mg

100 Tablets/ 1 Tablet Per Packet

Pseudoephedrine Free Sinus Relief

Pull To Open

• For sinus headache, pain, pressure, and congestion

Compare active ingredients to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Dosage and Administration (34068-7)

Directions

■ do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRug Factr

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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless

■ symptoms do not improve within 7 days or are accompanied by fever

Section 50567-7 (50567-7)

When using this product

■ do not exceed recommended dosage

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ heart disease

■ high blood pressure

■ thyroid disease

■ diabetes

■ trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments? 800-480-5855

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Section 60561-8 (60561-8)

Other information

■ store at room temperature 59º-86º F (15º-30º C)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Unishield Sinus Decongestant Label

Unishield

Sinus Decongestant

Phenylephrine HCl 10 mg

100 Tablets/ 1 Tablet Per Packet

Pseudoephedrine Free Sinus Relief

Pull To Open

• For sinus headache, pain, pressure, and congestion

Compare active ingredients to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:57.423285 · Updated: 2026-03-14T23:10:03.511025