271 - Phenylephrine Hcl 5mg

271 - Phenylephrine Hcl 5mg
SPL v6
SPL
SPL Set ID 7a3098b4-381c-4f32-97a7-87b53fd64428
Route
ORAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 271 Shape: round Color: red Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Phenylephrine HCl 5mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 5mg

Use(s)
  • temporarily relieves sinus congestion and

    pressure
  • temporarily relieves nasal congestion due to the

    common cold, hay fever or other upper respiratory

    allergies

Storage
  • store at room temperature 20°– 25°C (68°– 77°F)
Warnings

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.

Questions

Call 1-888-952-0050 Monday through Friday

Directions

Adults and children 12 years and over: 1 tablet every 4 hours

  • do not take more than 6 tablets in 24 hours

Children under 12 years ask a doctor

Other Information
  • do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s)

Phenylephrine HCl 5mg

Inactive Ingredients

croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.

May contain propylene glycol

Pregnancy/breastfeeding

ask a health professional before use

Principal Display Panel
Decongestant PE
When Using This Product

do not exceed recommended dose



Ask A Doctor Before Use If
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

Keep Out of Reach of Children

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


Structured Label Content

Use(s)
  • temporarily relieves sinus congestion and

    pressure
  • temporarily relieves nasal congestion due to the

    common cold, hay fever or other upper respiratory

    allergies

Purpose

Nasal decongestant

Storage
  • store at room temperature 20°– 25°C (68°– 77°F)
Warnings

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.

Questions

Call 1-888-952-0050 Monday through Friday

Directions

Adults and children 12 years and over: 1 tablet every 4 hours

  • do not take more than 6 tablets in 24 hours

Children under 12 years ask a doctor

Other Information (Other information)
  • do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Phenylephrine HCl 5mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.

May contain propylene glycol

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use

Principal Display Panel
Decongestant PE
When Using This Product (When using this product)

do not exceed recommended dose



Ask A Doctor Before Use If (Ask a doctor before use if)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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