ALKA-SELTZER PLUS COLD DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate 
Bayer HealthCare LLC.

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Alka-Seltzer Plus® Cold Day & Night Effervescent Tablets

Alka-Seltzer Plus® Cold Day Effervescent Tablets

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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

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 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 ● 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 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

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: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat

Inactive ingredients acesulfame potassium, anhydrous citric

acid, aspartame, calcium silicate, dimethicone, docusate sodium,

flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM –

5PM EST)

Alka-Seltzer Plus® Cold Night Effervescent Tablets

SPL

Active ingredients (in each tablet)

Aspirin 500 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

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

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 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 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

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

Other information

● each tablet contains: sodium 476 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, dimethicone, docusate sodium,

flavors (natural & artificial), mannitol, povidone, sodium benzoate,

sodium bicarbonate

Questions or comments?

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

Fri 9AM – 5PM EST)

Package Display Label

Alka-Seltzer

PLUS®

DAY NON-DROWSY

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Bitartrate / Nasal Decongestant

12 EFFERVESCENT TABLETS

NIGHT

ASPIRIN (NSAID) / Pain Reliever-Fever Reducer

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Antihistamine

Phenylephrine Bitartrate / Nasal Decongestant

8 EFFERVESCENT TABLETS

Carton labelProduct carton 2

ALKA-SELTZER PLUS COLD DAY AND NIGHT 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1550
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1550-201 in 1 CARTON; Type 0: Not a Combination Product09/14/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 POUCH 12 
Part 24 POUCH
Part 1 of 2
ALKA-SELTZER PLUS COLD DAY 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;DAY
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/14/2018
Part 2 of 2
ALKA-SELTZER PLUS COLD NIGHT 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate tablet, effervescent
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MANNITOL (UNII: 3OWL53L36A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMONImprint Code ASP;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/14/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2023
Document Id: 0bb5609f-8a07-c67e-e063-6394a90a1929
Set id: 75894849-a0ba-57be-e053-2a91aa0a049a
Version: 5
Effective Time: 20231204
 
Bayer HealthCare LLC.