205r Phenylephrine Green Guard Allergy 2 Relief

205r Phenylephrine Green Guard Allergy 2 Relief
SPL v10
SPL
SPL Set ID 16fddca9-a66b-41e6-9423-eaf091d3971e
Route
ORAL
Published
Effective Date 2021-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Lactose Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: 271 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Drug Facts


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

Dosage and Administration

Directions

  • do not use more than directed

​Adults and children: (12 years and older) Take 2 tablets every 4 - 6 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Ask a doctor

Description

Drug Facts

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

■ 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? 1-800-869-6970

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 5mg

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
Drug Facts

Drug Facts

Green Guard Allergy 2 Relief Label

Allergy 2 relief™

Pull To Open

Tire Para Abrir

Tabletas para el alivio de

sintomas alergicos

Phenylephrine HCl 5mg/ Hidrocloruro de Fenilefrina 5mg

Nasal Decongestant/ Descongestivo Nasal

Green Guard®

50 Packets of 2 Tablets

100 Tablets

Order #2230

Distributed by Green Guard®, St Louis, MO 63045


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

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

​Adults and children: (12 years and older) Take 2 tablets every 4 - 6 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

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

■ 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? 1-800-869-6970

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 5mg

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
Drug Facts

Drug Facts

Green Guard Allergy 2 Relief Label

Allergy 2 relief™

Pull To Open

Tire Para Abrir

Tabletas para el alivio de

sintomas alergicos

Phenylephrine HCl 5mg/ Hidrocloruro de Fenilefrina 5mg

Nasal Decongestant/ Descongestivo Nasal

Green Guard®

50 Packets of 2 Tablets

100 Tablets

Order #2230

Distributed by Green Guard®, St Louis, MO 63045


Advanced Ingredient Data


Raw Label Data

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