Gencare-nasal Decongestant Pe

Gencare-nasal Decongestant Pe
SPL v1
SPL
SPL Set ID 596ec923-56a0-4b6e-a69c-8d740feb75a2
Route
ORAL
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose Dicalcium Phosphate Croscarmellose Sodium Magnesium Stearate Polyvinyl Alcohol Hypromellose, Unspecified Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Talc Titanium Dioxide Fd&c Red No. 40 Aluminum Lake Indigotindisulfonate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18

Description

Phenylephrine HCl 10mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10mg

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 50567-7

When using this product do not exceed recommended dose.

Section 51945-4

Section 53414-9

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

Uses: 
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings

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.

Directions:
  • take 1 tablet every 4 hours
  • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
  • children under 12 years: ask a doctor
Other Information
  • store between 20-25°C (68-77°F)
  • do not use if seal under cap is broken or missing
Inactive Ingredients

Crosscarmellose Soidum, Dibasic Calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Purified water. Readycoat Red contains: polyvinyl alcohol, polyethylene glycol, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, allura red lake, indigo carmine lake.

Questions Or Comments?

Call (732) 994-2808 or email [email protected]

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever.
Active Ingredient (in Each Tablet)

Phenylephrine HCl 10mg

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

Structured Label Content

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 50567-7 (50567-7)

When using this product do not exceed recommended dose.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

Uses:  (USES: )
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings (WARNINGS)

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.

Directions: (DIRECTIONS:)
  • take 1 tablet every 4 hours
  • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
  • children under 12 years: ask a doctor
Other Information (OTHER INFORMATION)
  • store between 20-25°C (68-77°F)
  • do not use if seal under cap is broken or missing
Inactive Ingredients (INACTIVE INGREDIENTS)

Crosscarmellose Soidum, Dibasic Calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Purified water. Readycoat Red contains: polyvinyl alcohol, polyethylene glycol, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, allura red lake, indigo carmine lake.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call (732) 994-2808 or email [email protected]

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.
Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Phenylephrine HCl 10mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)