Your browser does not support JavaScript! ALKA-SELTZER PLUS (ASPIRIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC, CONSUMER CARE]
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ALKA-SELTZER PLUS (aspirin, doxylamine succinate, phenylephrine bitartrate, and dextromethorphan hydrobromide) tablet, effervescent
[Bayer HealthCare LLC, Consumer Care]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredients (in each tablet)Purposes
Aspirin 500 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal decongestant

Uses

  • 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

Warnings

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.

Directions

  • 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 www.alkaseltzerplus.com

PRINCIPAL DISPLAY PANEL - Shipper Label

ALKA-SELTZER PLUS®
NIGHT COLD FORMULA

3200 TABLETS 1600 PIECES

SHIPPER
CODE
1 00 16500 54213 8

MADE IN
MEXICO

PRODUCT CODE

82411594

STORE AT ROOM
TEMPERATURE.
AVOID EXCESSIVE HEAT

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

Principal Display Panel – Shipper Label
ALKA-SELTZER PLUS   NIGHT COLD MEDICINE
aspirin, doxylamine succinate, phenylephrine bitartrate, and dextromethorphan hydrobromide tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0280-1430
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin500 mg
Doxylamine succinate (Doxylamine) Doxylamine succinate6.25 mg
Phenylephrine bitartrate (Phenylephrine) Phenylephrine bitartrate7.8 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide10 mg
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize26mm
FlavorLEMONImprint Code A;S;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1430-321600 in 1 CASE
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2010
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 7/2010
 
Bayer HealthCare LLC, Consumer Care

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