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Name:Alka-seltzer Plus Night Cold Medicine
Manufacturer:Bayer Healthcare Llc, Consumer Care
Category:Over-the-counter (OTC) Marketed Drugs

Alka-Seltzer Plus® Night Cold FormulaEffervescent Tablets

ALKA-SELTZER PLUS  NIGHT COLD MEDICINE - aspirin, doxylamine succinate, phenylephrine bitartrate and dextromethorphan hydrobromide tablet, effervescent 
Bayer HealthCare LLC, Consumer Care

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® Night Cold Formula
Effervescent Tablets

Drug Facts

Active ingredients (in each tablet) Purposes
Aspirin 500 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Phenylephrine bitartrate 7.8 mg Nasal decongestant


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


Reye's syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

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

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • 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

  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
    • anticoagulation (blood thinning)
    • diabetes
    • gout
    • arthritis
  • taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • ringing in the ears or loss of hearing occurs
  • 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.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

  • each tablet contains: sodium 474 mg
  • Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

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




1 00 16500 54213 8





Bayer HealthCare LLC
Consumer Care
P.O. Box 1910, Morristown, NJ
07962-1910 USA

Principal Display Panel – Shipper Label

aspirin, doxylamine succinate, phenylephrine bitartrate, and dextromethorphan hydrobromide tablet, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1430
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 500 mg
Doxylamine succinate (Doxylamine) Doxylamine succinate 6.25 mg
Phenylephrine bitartrate (Phenylephrine) Phenylephrine bitartrate 7.8 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide 10 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 26mm
Flavor LEMON Imprint Code A;S;NT
# Item Code Package Description Multilevel Packaging
1 NDC:0280-1430-32 1600 POUCH ( POUCH) in 1 CASE contains a POUCH
1 2 TABLET, EFFERVESCENT ( TABLET) in 1 POUCH This package is contained within the CASE (0280-1430-32)

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

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 07/2010 Bayer HealthCare LLC, Consumer Care

Reproduced with permission of U.S. National Library of Medicine

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