ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ- aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent 
Bayer HealthCare LLC.

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Alka-Selzer Plus Severe Cold PowerFast Fizz Night effervescent tablets UI 1614897

Drug Facts

Active ingredients (in each tablet) Purposes

Aspirin 325 mg (NSAID)*….………………….Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Doxylamine succinate 6.25 mg…………………………...…Antihistamine

Phenylephrine bitartrate 7.8 mg.......…………….….Nasal decongestant

*nonsteroidal anti-inflammatory drug

Uses

Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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
  • 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

  • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have
      • asthma
      • diabetes
      • thyroid disease
      • glaucoma
      • cough that occurs 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
    • gout
    • diabetes
    • 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.
  • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • 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 a 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 every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.

● children under 12 years of age: do not use

Other information
each tablet contains: potassium 78 mg; sodium 356 mg
● store at room temperature. Avoid excessive heat.

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Carton 20 count

Alka-Seltzer Plus®

SEVERE

Cold

LEMON

POWERFAST FIZZ™ SEE NEW DOSING DIRECTIONS

NIGHT

Aspirin (NSAID)/Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistmine

Phenylephrine Bitartrate / Nasal Decongestant

20 EFFERVESCENT TABLETS

Carton

ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ 
aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0068
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
POVIDONE (UNII: FZ989GH94E)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMONImprint Code ASP;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0068-0110 in 1 CARTON07/12/2021
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/12/2021
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0bb5b6b0-7f99-d7a0-e063-6394a90aeafb
Set id: c1fae6c7-bbac-1320-e053-2a95a90aac5a
Version: 3
Effective Time: 20231204
 
Bayer HealthCare LLC.