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

Purpose

Nasal decongestant

Description

Phenylephrine HCl 5mg


Medication Information

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.

Active Ingredient

Phenylephrine HCl 5mg

Uses

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

Purpose

Nasal decongestant

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

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

Description

Phenylephrine HCl 5mg

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).

Packaging

Drug Facts

Questions Or Comments?

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

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


Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

Phenylephrine HCl 5mg

Uses

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

Purpose

Nasal decongestant

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

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

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).

Packaging

Drug Facts

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)