ALKA-SELTZER PLUS MAX COUGH, MUCUS AND CONGESTION- dextromethorphan hydrobromide and guaifenesin capsule, liquid filled 
Bayer HealthCare 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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Alka-Seltzer Plus ® Max Cough, Mucus & Congestion

Drug Facts

Active ingredients (in each capsule)Purpose
Dextromethorphan hydrobromide 10 mgCough suppressant
Guaifenesin 200 mgExpectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

Do not use

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

Ask a doctor before use if you have

  • cough with excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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.

Directions

  • do not take more than the recommended dose
adults and children 12 years and overtake 2 capsules every 4 hoursdo not exceed 12 capsules in 24 hours
children under 12 yearsdo not use

Other information

  • store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

OFFICIAL SPONSOR

Alka-
Seltzer
PLUS ®

  • Dextromethorphan
    hydrobromide /
  • Guaifenesin / Expectorant

MAX COUGH,
MUCUS & CONGESTION

Controls Cough • Relieves Chest Congestion
Thins & Loosens Mucus

20 LIQUID GELS (Liquid Filled Capsules)

Principal Display Panel - 20 Capsule Carton
ALKA-SELTZER PLUS MAX COUGH, MUCUS AND CONGESTION 
dextromethorphan hydrobromide and guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize20mm
FlavorImprint Code AS;MC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1001-202 in 1 CARTON09/27/201311/01/2015
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/27/201311/01/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2017
Document Id: 60cb0eea-576e-1aba-e053-2991aa0a80b9
Set id: 7b6c90cc-91a8-4fbc-832b-c9eb38a4ffc8
Version: 2
Effective Time: 20171220
 
Bayer HealthCare LLC.