Nasal Decongestant Pe- Phenylephrine Hcl 10 Mg Tablet

Nasal Decongestant Pe- Phenylephrine Hcl 10 Mg Tablet
SPL v2
SPL
SPL Set ID 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2
Route
ORAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Microcrystalline Cellulose Dibasic Calcium Phosphate Dihydrate Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Fd&c Red No. 40 Aluminum Lake Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-17

Description

Phenylephrine HCl 10mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10mg

Uses:

■ temporarily relieves sinus congestion and pressure

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

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.

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: 

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide

Questions Or Comments ? 

Call 1 (718) 337-8733 or visit: [email protected]

Stope 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

Uses: (USES:)

■ temporarily relieves sinus congestion and pressure

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

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

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: )

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide

Questions Or Comments ?  (QUESTIONS OR COMMENTS ? )

Call 1 (718) 337-8733 or visit: [email protected]

Stope Use and Ask A Doctor If  (Stope 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)