ACTIFED- phenylephrine hydrochloride tablet

ACTIFED by

Drug Labeling and Warnings

ACTIFED by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 5mg

Purpose

Nasal decongestant

Uses

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

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.

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).

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

Questions or comments?

Call 1-888-779-2877 M-F 9AM-5PM EST
Belmora LLC 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

SPL UNCLASSIFIED SECTION

Quick Nasal Decongestant Relief!
Non-Drowsy/Sugar Free

KEEP THE BOX FOR COMPLETE PRODUCT INFORMATION

Packaging

INGREDIENTS AND APPEARANCE

ACTIFED 
phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	271
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-119-01	50 in 1 BOX	08/01/2023
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2023

Labeler - Belmora LLC (112753244)