ALKA-SELTZER PLUS SEVERE COUGH AND COLD  DAY AND NIGHT - acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin, and doxylamine succinate   
Bayer HealthCare LLC, Consumer Care

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 Severe Cough & Cold Liquid Gels

Drug Facts

Active ingredients (in each capsule)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves these symptoms due to a cold or flu:
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • relieves the impulse to cough to help you get to sleep
  • 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.
  • 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 you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough with excessive phlegm (mucus)

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, 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

Alka-Seltzer Plus® Night Severe Cough & Cold 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.
  • 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 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

PRINCIPAL DISPLAY PANEL - Kit Carton

New Cough
Co-Pack!

Alka-
Seltzer
PLUS
®

SEVERE COUGH & COLD

NON
DROWSY DAY

Acetaminophen / Pain reliever-fever reducer
Dextromethorphan hydrobromide / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant

BAYER

Relieves: Mucus • Cough
Headache, Fever, Sore Throat
Nasal & Chest Congestion

12 LIQUID GELS (Liquid Filled Capsules)

NIGHT

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

Relieves: Cough
Nasal Congestion • Runny Nose
Headache, Fever, Sore Throat

8 LIQUID GELS (Liquid Filled Capsules)

Principal Display Panel - Kit Carton
ALKA-SELTZER PLUS SEVERE COUGH AND COLD   DAY AND NIGHT
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1187
Packaging
#Item CodePackage Description
1NDC:0280-1187-201 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 SEVERE COUGH AND COLD   DAY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and guaifenesin capsule, liquid filled
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
guaifenesin (guaifenesin) guaifenesin200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C red no. 40 
water 
gelatin 
glycerin 
mannitol 
polyethylene glycol 400 
povidone 
propylene glycol 
shellac 
sorbitan 
sorbitol 
titanium dioxide 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize25mm
FlavorImprint Code AS;M
Contains    
Packaging
#Item CodePackage Description
112 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 SEVERE COUGH AND COLD   NIGHT
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 
propylene glycol 
shellac 
sorbitan 
sorbitol 
titanium dioxide 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize25mm
FlavorImprint Code AS;NITE
Contains    
Packaging
#Item CodePackage Description
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/201309/17/2013
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 09/2013
 
Bayer HealthCare LLC, Consumer Care