Valumeds Nasal Decongestant, Phenylephrine Hcl

SPL v2

SPL

SPL Set ID 21676b0c-6be2-464c-ae91-92e5f0d0087d

Route

ORAL

Published

Effective Date 2025-10-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg)

Inactive Ingredients

Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Red No. 40 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 3P Shape: round Color: red Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses

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

Warnings

Directions

adults and children 12 years and over	take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours
children under 12 years	ask a doctor

Do Not Use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, 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 a MAOI, ask a doctor or pharmacist before taking this product.

Drug Facts

Other Information

store between 20°–25°C (68°–77°F)

Package Labeling:

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, FD&C red no. 40, hypromellose, indigo carmine lake, magnesium stearate, methacrylic acid polymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

Call 1-908-242-6108Mon-Fri 8:00 AM to 5:00PM EST

When Using This Product

do not exceed recommended dose

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

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

• 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

Warnings

Directions

adults and children 12 years and over	take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours
children under 12 years	ask a doctor

Do Not Use (Do not use)

Drug Facts

Other Information (Other information)

store between 20°–25°C (68°–77°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-908-242-6108Mon-Fri 8:00 AM to 5:00PM EST

When Using This Product (When using this product)

do not exceed recommended dose

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 right away. (1-800-222-1222)

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

Phenylephrine HCl 10 mg

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

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Raw Label Data

All Sections (JSON)

{"Uses": "• 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", "Directions": " adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor", "Do not use": "if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, 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 a MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "store between 20°–25°C (68°–77°F)", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate, FD&C red no. 40, hypromellose, indigo carmine lake, magnesium stearate, methacrylic acid polymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide", "Questions or comments?": "Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00PM EST", "When using this product": "do not exceed recommended dose", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "If pregnant or breast-feeding,": "ask a health professional before use.", "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)", "Active Ingredient (in each tablet)": "Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.623603 · Updated: 2026-03-14T23:11:54.825001