Medique And Dover Phenylephrine Hcl 5mg

Medique And Dover Phenylephrine Hcl 5mg
SPL v13
SPL
SPL Set ID d7d62ac1-1333-4366-884b-26537766ce38
Route
ORAL
Published
Effective Date 2021-12-28
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 Polyethylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: 271 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-12-30 Until 2027-08-31

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
Description

Drug Facts

Section 42229-5

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 (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? 1-800-634-7680

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
Dover Sudanyl Label

Dover Sudanyl PE

Nasal and Nasal Decongestant

Non-Drowsy, Sugar Free

Phenylephrine HCl 5mg

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Resistant

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

205r Medique Medi Phenyl Label

Medique®

Medi-Phenyl

Pseudoephedrine Free

Sin seudoefedrina

Nasal Decongestant • Phenylephrine HCl 5mg

Decongestivo Nasal • Hidrocloruro de fenilefrina 5 mg

Pull to Open

Tire Para Abrir

500 Tablets

(250 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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? 1-800-634-7680

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
Dover Sudanyl Label

Dover Sudanyl PE

Nasal and Nasal Decongestant

Non-Drowsy, Sugar Free

Phenylephrine HCl 5mg

Dover Pharmaceutical

Products of the highest quality and effectiveness

Tamper Resistant

Sealed Packets

Unit Dose Packs

500 Tablets

(250 Packets of 2)

205r Medique Medi Phenyl Label (205R Medique Medi-Phenyl Label)

Medique®

Medi-Phenyl

Pseudoephedrine Free

Sin seudoefedrina

Nasal Decongestant • Phenylephrine HCl 5mg

Decongestivo Nasal • Hidrocloruro de fenilefrina 5 mg

Pull to Open

Tire Para Abrir

500 Tablets

(250 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


Advanced Ingredient Data


Raw Label Data

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