You are here: Home > Over-the-counter (OTC) Drugs > A > Alka-seltzer Plus Fast Packs Cold And Flu Formula (Bayer Corporation Consumer Care Division)

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®

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.

----------

Alka-Seltzer
Plus®

Drug Facts

Active ingredients (in each powder packet) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Chlorpheniramine maleate 4 mg Antihistamine
Phenylephrine hydrochloride 10 mg Nasal decongestant

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 5 powder packets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use to sedate children.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase 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.
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occurs

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 & FLU
formula

Nasal Congestion - Runny Nose
Headache + Body Ache - Sore Throat
Sinus Pressure

BAYER

10
SINGLE DOSE
POWDER PACKETS

PRINCIPAL DISPLAY PANEL - 10 Single Dose Powder Packet Carton

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:0280-7190-10 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: 06/2010 Bayer Corporation Consumer Care Division



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


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

OTC Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback