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Alka-Seltzer Plus Severe Cold, Mucus and Congestion

Dosage form: capsule, liquid filled
Ingredients: Acetaminophen 250mg, Dextromethorphan hydrobromide 10mg, guaifenesin 200mg, Phenylephrine hydrochloride 5mg
Labeler: Bayer HealthCare LLC, Consumer Care
NDC Code: 0280-1159

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® Severe Cold, Mucus & Congestion Liquid Gels

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine hydrochloride 5 mgNasal decongestant

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves these symptoms due to a cold or flu:
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • relieves the impulse to cough to help you get to sleep
  • temporarily reduces fever


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

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.

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 12 capsules in 24 hours or as directed by a doctor
  • children under 12 years: do not use

Other information
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C red #40, gelatin, glycerin, 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

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton

Acetaminophen / Pain reliever-fever
reducer • Dextromethorphan
hydrobromide / Cough suppressant • Guaifenesin /
Expectorant • Phenylephrine HCl / Nasal




Relieves Headache, Fever & Sore Throat • Controls Cough
Relieves Nasal & Chest Congestion • Thins & Loosens Mucus

20 LIQUID GELS (Liquid Filled Capsules)

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1159
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide10 mg
guaifenesin (guaifenesin) guaifenesin200 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C red No. 40 
polyethylene glycol 400 
povidone K30 
propylene glycol 
titanium dioxide 
Product Characteristics
ColorREDScoreno score
FlavorImprint CodeAS;M
#Item CodePackage Description
1NDC:0280-1159-201 BLISTER PACK in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2013
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 05/2013
Bayer HealthCare LLC, Consumer Care

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.