ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit

Alka-Seltzer Plus Severe Cold PowerFast Fizz by

Drug Labeling and Warnings

Alka-Seltzer Plus Severe Cold PowerFast Fizz by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Product

Alka-Seltzer Plus Severe cold PowerFast Fizz Day Effervescent Tablets

Drug Facts

Drug Facts

Active ingredients

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

Uses

Uses

· temporarily relieves these symptoms due to a cold with cough:

· minor aches and pains · headache · cough

· nasal and sinus congestion · sore throat

· 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

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

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 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

Ask a doctor or pharmacist before use if you are

· taking a prescription drug for

· gout · diabetes · arthritis

When using

When using this product do not exceed recommended dosage

Stop use

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

Pregnant or breastfeeding

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

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

Directions

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: do not use

Other information

Other information
● each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Inactive ingredients

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

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

Drug Facts

Alka-Seltzer Plus Sever Cold PowerFast Fizz Night Effervescent Tablets

Active ingredients

Active ingredients (in each tablet) Purposes

Aspirin 500 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

Uses

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

● 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 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

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 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

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 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

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

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

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

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

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

Directions

Directions

● adults and children 12 years and over: take 2 tablets fully dissolved

in 4 oz of water every 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

Other information
● each tablet contains: potassium 80 mg; sodium 356 mg

● store at room temperature. Avoid excessive heat.

Inactive ingredients

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

Questions or comments

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

Package display

Alka-Seltzer

Plus®

SEVERE

Cold

POWERFAST FIZZ™

DAY/CITRUS

NIGHT/LEMON

NEW IMPROVED FLAVOR

DAY NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

• Nasal Congestion
• Headache + Body Ache
• Cough
• Sore Throat
• Sinus Pressure

12 EFFERVESCENT TABLETS

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 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-0025

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-0025-01	1 in 1 CARTON; Type 0: Not a Combination Product	04/01/2020

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

Part 1 of 2

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

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/20/2020

Part 2 of 2

ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY NON DROWSY 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM SILICATE (UNII: S4255P4G5M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIMETHICONE (UNII: 92RU3N3Y1O)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POVIDONE (UNII: FZ989GH94E)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MANNITOL (UNII: 3OWL53L36A)
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)

Product Characteristics
Color	white (Speckled)	Score	no score
Shape	ROUND	Size	25mm
Flavor	CITRUS	Imprint Code	ASP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2020

Labeler - Bayer HealthCare LLC. (112117283)