ACTIFED- phenylephrine hydrochloride tablet 
Belmora LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIFED

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

Quick Nasal Decongestant Relief!
Non-Drowsy/Sugar Free

KEEP THE BOX FOR COMPLETE PRODUCT INFORMATION

Packaging

ACTIFED-119

ACTIFED 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 271
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-119-0150 in 1 BOX08/01/2023
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2023
Labeler - Belmora LLC (112753244)

Revised: 8/2023
Document Id: fa049b30-8416-43f0-925f-26ec17a1d68a
Set id: 65c23d86-9634-4d9f-93cd-9efa866cd7f5
Version: 1
Effective Time: 20230801
 
Belmora LLC