ALKA-SELTZER PLUS DAY AND NIGHT COLD- alka-seltzer plus day and night cold 
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Alka-Seltzer Plus Day & Night Cold Formula Effervescent Tablets

Alka-Seltzer Plus Day Non-Drowsy Cold Effervescent Tablets

Alka-Seltzer Plus Day Non-Drowsy Cold Effervescent Tablets

Drug Facts

Drug Facts

Active ingredients (in each tablet)

*
nonsteroidal anti-inflammatory drug
Active ingredients (in each tablet)Purposes
Aspirin 325 mg (NSAID) *Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Phenylephrine bitartrate 7.8 mgNasal 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

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

● 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, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

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

Alka-Seltzer Plus® Night Cold Effervescent Tablets

Alka-Seltzer Plus® Night Cold Effervescent Tablets

Drug Facts

Active ingredients (in each tablet)

*
nonsteroidal anti-inflammatory drug
Active ingredients (in each tablet)Purposes
Aspirin 500 mg (NSAID) *Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine bitartrate 7.8 mgNasal decongestant

· 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

● 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

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

· 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

● each tablet contains: sodium 474 mg
● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● store at room temperature. Avoid excessive heat.

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

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

ASPDNCOLDEFF

ALKA-SELTZER PLUS  DAY AND NIGHT COLD
alka-seltzer plus day and night cold kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1140
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1140-201 in 1 CARTON01/09/201511/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 POUCH 12 
Part 24 POUCH
Part 1 of 2
ALKA-SELTZER PLUS  DAY MULTIP-SYMPTOMS NON-DROWSY COLD
aspirin,dextromethorphan hydrobromide,phenylephrine bitartrate tablet, effervescent
Product Information
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
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;DAY
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/09/2015
Part 2 of 2
ALKA-SELTZER PLUS  NIGHT MULTI-SYMPTOM COLD
aspirin,dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate tablet, effervescent
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorLEMONImprint Code ASP;NT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34101/09/201511/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2017
 
Bayer HealthCare LLC.