ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate 
Bayer HealthCare LLC.

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Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night Effervescent Tablets UI 1614460 & 161897

Drug Facts

Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

Active ingredients (in each tablet) Purposes

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

Dextromethorphan hydrobromide 10 mg……………………Cough suppressant

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:

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

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

● are age 60 or older

● have had stomach ulcers or bleeding problems

● take a blood thinning (anticoagulant) or steroid drug

● take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)

● have 3 or more alcoholic drinks every day while using this product

● take more or for a longer time than directed

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

● 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 itsingredients

● 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 •thyroid •disease diabetes
    • cough that occurs 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
    • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
    • gout
    • diabetes
    • arthritis

When using this product do not exceed recommended dosage.

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 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

Other information

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

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

Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

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 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

Other information

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)

Alka-Seltzer Plus®

SEVERE COLD

DAY/CITRUS

NIGHT LEMON

POWERFAST FIZZ™

DAY NON-DROWSY

ASPIRIN (NSAID)/Pain Reliever - Fever Reducer

DEXTROMETHORPHAN HBr/Cough Suppressant

PHENYLEPHRINE BITARTRATE/Nasal Decongestant

12 EFFERVESCENT TABLETS

NEW NIGHT DOSING DIRECTIONS

NIGHT

Aspirin (NSAID)/Pain Reliever-Fever Reducer

Dextromethorphan HBr/Cough Suppressant

Doxylamine Succinate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

8 EFFERVESCENT TABLETS

Carton 20 count

ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0086
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0086-011 in 1 CARTON; Type 0: Not a Combination Product04/29/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 132 POUCH 32 
Part 216 POUCH 16 
Part 1 of 2
ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY 
asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
Product Information
Item Code (Source)NDC:00280-0020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/29/2022
Part 2 of 2
ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ 
aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
Product Information
Item Code (Source)NDC:0280-0068
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMONImprint Code ASP;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/27/2022
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0bb5d52f-42cb-950d-e063-6294a90a2a64
Set id: d7711cd6-5058-548d-e053-2a95a90ac54d
Version: 6
Effective Time: 20231204
 
Bayer HealthCare LLC.