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Name:Alka-seltzer Plus Fast Packs Cold And Flu Formula
Manufacturer:Bayer Corporation Consumer Care Division
Category:Over-the-counter (OTC) Marketed Drugs


ALKA-SELTZER PLUS FAST PACKS COLD AND FLU FORMULA  - acetaminophen, chlorpheniramine maleate and phenylephrine hydrochloride granule, effervescent 
Bayer Corporation Consumer Care Division

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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Drug Facts

Uses


  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • sore throat
  • temporarily reduces fever

Directions

  • adults and children 12 years and over:
    • dissolve contents of 1 powder packet in 6-8 ounces of hot or cold beverage: juice, tea, black coffee, or water
    • consume entire beverage within 15 minutes
  • take every 4 hours as needed
  • do not exceed 5 powder packets in 24 hours
  • children under 12 years: do not use

Other information

  • Phenylketonurics: Contains Phenylalanine 6 mg per powder packet
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavor, povidone, sucralose, sucrose

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.com


Distributed by:
Bayer HealthCare LLC
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 10 Single Dose Powder Packet Carton

FAST POWDER PACKS
FIZZ-FREE, TASTE FREE
IN MOST BEVERAGES
Alka-Seltzer
Plus
COLD And FLU Formula
Nasal Congestion - Runny Nose
Headache+Body Ache - Sore Throat
BAYER
10
SINGLE DOSE
POWDER PACKETS
../images_otc/alkaseltzer__AlkaSeltzerColdFluCarton.jpg
Carton Image


ALKA-SELTZER PLUS FAST PACKS COLD AND FLU FORMULA 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride granule, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-7190
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 650 mg
Chlorpheniramine maleate (Chlorpheniramine) Chlorpheniramine maleate 4 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Product Characteristics
Color white (White powder) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-7190-29 10 GRANULE, EFFERVESCENT ( PACKET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/01/2010

Labeler - Bayer Corporation Consumer Care Division (785159372)

Revised: 07/2010 Bayer Corporation Consumer Care Division



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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