ALKA-SELTZER PLUS  SEVERE SINUS CONGESTION AND COUGH- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
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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Alka-Seltzer
Plus®
SEVERE SINUS
CONGESTION & COUGH

Drug Facts

Active ingredients (in each capsule) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg Cough suppressant
Phenylephrine hydrochloride 5 mg Nasal decongestant

Uses

Warnings

Liver warning

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

  • more than 12 capsules in 24 hours, which is the maximum daily amount
  • 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

  • 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
  • thyroid disease
  • diabetes
  • cough with excessive phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

  • pain, cough, 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
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • 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

Other information

store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitan, sorbitol, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

See new warnings information

Alka-Seltzer
Plus
®

SEVERE SINUS
CONGESTION & COUGH
NON-DROWSY

SINUS FORMULA
Nasal + Sinus Congestion
Sinus Pressure
Headache + Pain
Cough

Phenylephrine HCl / Nasal decongestant
Dextromethorphan hydrobromide / Cough suppressant
Acetaminophen / Pain reliever-fever reducer

20
LIQUID GELS

(Liquid Filled Capsules)

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton
ALKA-SELTZER PLUS   SEVERE SINUS CONGESTION AND COUGH
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1180
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg
Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide 10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code AS;DS
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0280-1180-20 1 in 1 CARTON
1 20 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/01/2010
Labeler - Bayer Corporation Consumer Care Division (785159372)

Revised: 9/2010
Document Id: 8b4b35eb-d7eb-44c4-94c2-efbe071d866a
Set id: ca2d3c5f-a523-459d-b589-a5bc884023f7
Version: 1
Effective Time: 20100930
 
Bayer Corporation Consumer Care Division