ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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
PURPOSE
INDICATIONS & USAGE
Uses
- temporarily relieves these symptoms due to a cold with cough:
  - minor aches and pains
  - headache
  - sinus congestion and pressure
  - cough
  - sore throat
  - nasal congestion
- temporarily reduces fever
WARNINGS
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.
DOSAGE & ADMINISTRATION
Directions
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT

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

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

Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets
ACTIVE INGREDIENT

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
PURPOSE
INDICATIONS & USAGE
Uses
- temporarily relieves these symptoms due to a cold:
  - minor aches and pains
  - headache
  - runny nose
  - sinus congestion and pressure
  - cough
  - sneezing
  - sore throat
  - nasal congestion
- temporarily reduces fever
WARNINGS
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
- artake 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 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.
DOSAGE & ADMINISTRATION
Directions
- do not take more than the recommended dose
- do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
- adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
- children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
- each tablet contains: potassium 78 mg; sodium 356 mg
- store at room temperature. Avoid excessive heat.
INACTIVE INGREDIENT

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

Questions or comments? 1-800-986-0369 (Mon-

Fri 9AM – 5PM EST)
PRINCIPAL DISPLAY PANEL
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
- Nasal Decongestant
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
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
- Nasal congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0069

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0280-0069-01	1 in 1 CARTON; Type 0: Not a Combination Product	08/05/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	12 POUCH	12
Part 2	8 POUCH	8

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: 0280-0024
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	CITRUS	Imprint Code	ASP
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/05/2021

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 Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

Ingredient Name	Strength
Inactive Ingredients
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
DIMETHICONE (UNII: 92RU3N3Y1O)
CALCIUM SILICATE (UNII: S4255P4G5M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	LEMON, LEMON	Imprint Code	ASP;NT
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/05/2021

Labeler - Bayer HealthCare LLC. (112117283)

ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit

Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night by

Drug Labeling and Warnings

Drug Details [pdf]