Alka-Seltzer Plus Day and Night Multi-Symptom Cold and Flu Formula

Dosage form: kit
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg; Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg, Doxylamine succinate 6.25mg
Labeler: Bayer HealthCare LLC, Consumer Care
NDC Code: 0280-1146

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.

Alka-Seltzer Plus® Day & Night Multi-Symptom Cold & Flu Formula

Alka-Seltzer Plus® Day Non-Drowsy
Cold & Flu Liquid Gels

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • 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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

  • 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
  • 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor
  • children under 12 years: do not use

Other information
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

 

Alka-Seltzer Plus® Night
Cold & Flu Liquid Gels

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • cough
    • sore throat
    • runny nose
    • sneezing
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 10 capsules in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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.
  • in children under 12 years of age

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • 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
  • 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
  • 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, simethicone, sorbitan, sorbitol, titanium dioxide

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Distributed by:
Bayer HealthCare LLC
Consumer Care
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - Capsule Kit Carton

NEW DIRECTIONS
NEW LOOK

Alka-
Seltzer
PLUS
®

NON DROWSY DAY

MULTI -SYMPTOM COLD & FLU FORMULA

Acetaminophen / Pain reliever-fever reducer
Dextromethorphan hydrobromide / Cough suppressant
Phenylephrine HCI / Nasal decongestant

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

12 LIQUID GELS
(Liquid Filled Capsules)

NIGHT

Acetaminophen / Pain reliever-fever reducer
Dextromethorphan hydrobromide / Cough suppressant
Doxylamine succinate / Antihistamine
Phenylephrine HCI / Nasal decongestant

Nasal Congestion
Cough•Headache & Body Ache
Runny Nose
Sore Throat

8 LIQUID GELS
(Liquid Filled Capsules)

ALKA-SELTZER PLUS  DAY AND NIGHT MULTI-SYMPTOM COLD AND FLU FORMULA
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1146
Packaging
#Item CodePackage Description
1NDC:0280-1146-201 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK
Part 1 of 2
ALKA-SELTZER PLUS  DAY MULTI-SYMPTOM COLD AND FLU FORMULA
acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
D&C YELLOW NO. 10 
gelatin 
glycerin 
mannitol 
polyethylene glycol 400 
povidone K30 
propylene glycol 
shellac 
titanium dioxide 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize25mm
FlavorImprint CodeAS;DC
Contains    
Packaging
#Item CodePackage Description
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/30/2012
Part 2 of 2
ALKA-SELTZER PLUS  NIGHT MULTI-SYMPTOM COLD AND FLU FORMULA
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and doxylamine succinate capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Doxylamine succinate (Doxylamine) Doxylamine succinate6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
gelatin 
glycerin 
mannitol 
polyethylene glycol 400 
povidone K30 
propylene glycol 
shellac 
sorbitan 
sorbitol 
titanium dioxide 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize25mm
FlavorImprint CodeAS;NITE
Contains    
Packaging
#Item CodePackage Description
18 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/30/2012
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 05/2012
 
Bayer HealthCare LLC, Consumer Care

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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