Actifed

Actifed
SPL v2
SPL
SPL Set ID 65c23d86-9634-4d9f-93cd-9efa866cd7f5
Route
ORAL
Published
Effective Date 2023-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Phenylephrine HCl 5mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 5mg

Uses

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

Section 42229-5

Quick Nasal Decongestant Relief!

Non-Drowsy/Sugar Free

KEEP THE BOX FOR COMPLETE PRODUCT INFORMATION

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).

Warnings

Do not use • If you are now taking a prescription monoamineoxidase 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.

When using this product do not exceed recommended dosage

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland

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

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

Packaging

Directions

do not use more than directed

Adults & Children:

 (12 years & older)
 Take 2 tablets every 4-6 hours.

 Do not take more than 12 tablets in 24 hours.
Children under 12 years:  Ask a doctor

Drug Facts

Other Information

• store at room temperature 59°-86° F (15°-30° C).

• tamper evident sealed packets.

• do not use any opened or torn packets

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

Questions Or Comments?

Call 1-888-779-2877 M-F 9AM-5PM EST

Belmora LLC 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

Active Ingredient (in Each Tablet)

Phenylephrine HCl 5mg


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Quick Nasal Decongestant Relief!

Non-Drowsy/Sugar Free

KEEP THE BOX FOR COMPLETE PRODUCT INFORMATION

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).

Purpose

Nasal decongestant

Warnings

Do not use • If you are now taking a prescription monoamineoxidase 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.

When using this product do not exceed recommended dosage

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland

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

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

Packaging

Directions

do not use more than directed

Adults & Children:

 (12 years & older)
 Take 2 tablets every 4-6 hours.

 Do not take more than 12 tablets in 24 hours.
Children under 12 years:  Ask a doctor

Drug Facts

Other Information

• store at room temperature 59°-86° F (15°-30° C).

• tamper evident sealed packets.

• do not use any opened or torn packets

Inactive Ingredients (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

Questions Or Comments? (Questions or comments?)

Call 1-888-779-2877 M-F 9AM-5PM EST

Belmora LLC 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

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

Phenylephrine HCl 5mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)