Physicianscare Sinus

Physicianscare Sinus
SPL v12
SPL
SPL Set ID a6daf3ef-f386-4de4-b38e-d0b90c9ae62b
Route
ORAL
Published
Effective Date 2022-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Lactose Magnesium Stearate Polyethylene Glycol 2000 Propylene Glycol Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 272 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-29

Description

Active ingredient (in each tablet) Phenylephrine HCl 10mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Temporarily relieves

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

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage.

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 doses in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Description

Active ingredient (in each tablet) Phenylephrine HCl 10mg

Section 34076-0

Other information

■ read all product information before using

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

■ tamper evident sealed packets

■ do not use any opened or torn packets

Section 50565-1

Keep out of the 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

■ 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 53414-9

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

Section 55105-1

Purpose

Nasal Decongestant

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10mg

Questions Or Comments?

1-800-835-2263

Physicians Care Sinus Label

980087

Physicians Care®

Non-Drowsy Sinus

Decongestant Clears Sinus Pressure & Congestion

Pull To Open

Coated Tablets

Tamper-Evident Packets of 1 Tablet

Do not use if packet is open or torn.

Phenylephrine HCl 10mg

50 Tabletsts (50 Packets, 1 tablet each)


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

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage.

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 doses in 24 hours.

Children under 12 years: Do not give to children under 12 years of age

Warnings and Precautions (34071-1)

Warnings

Section 34076-0 (34076-0)

Other information

■ read all product information before using

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

■ tamper evident sealed packets

■ do not use any opened or torn packets

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 right away.

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal Decongestant

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10mg

Questions Or Comments? (Questions or comments?)

1-800-835-2263

Physicians Care Sinus Label

980087

Physicians Care®

Non-Drowsy Sinus

Decongestant Clears Sinus Pressure & Congestion

Pull To Open

Coated Tablets

Tamper-Evident Packets of 1 Tablet

Do not use if packet is open or torn.

Phenylephrine HCl 10mg

50 Tabletsts (50 Packets, 1 tablet each)


Advanced Ingredient Data


Raw Label Data

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