ALKA-SELTZER PLUS SEVERE COLD AND COUGH NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid 
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® Severe Cold and Cough Night Liquid

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan hydrobromide 30 mg

Doxylamine succinate 12.5 mg

Purposes

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan hydrobromide 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

Antihistamine

Uses

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains 
    • headache 
    • sore throat
    • runny nose 
    • sneezing
    • cough due to minor throat and bronchial irritation
    • controls 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 4 doses 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

Allergy Alert:

acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening 
  • blisters 
  • rash 
  • hives
  • facial swelling 
  • asthma (wheezing) 
  • shock
  • If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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 ontains 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
  • 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 the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • may cause marked drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • pain or cough 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.

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

  • use only the enclosed green dosing cup designed for use with this product. Do not use any other dosing device.
  • do not take more than the recommended dose
  • do not exceed 4 doses in 24 hours or as directed by a doctor
  • adults and children 12 years and over: take 30 mL in the green dosing cup provided every 6 hours
  • children under 12 years: do not use
  • when using other Alka-Seltzer Plus® products, read each label carefully to ensure correct dosing and only use the dosing cup accompanying that specific product

Other information

  • each 30 mL contains: sodium 54 mg
  • store at 20 - 25°C (68 - 77°F). Avoid excessive heat above 40°C (104°F).

Inactive ingredients

alcohol, anhydrous citric acid, edetate disodium, FD&C Red #40, flavors, glycerin, polyethylene glycol, povidone, propionic acid, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

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ALKA-SELTZER PLUS SEVERE COLD AND COUGH NIGHT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POVIDONE (UNII: FZ989GH94E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0056-10245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/201505/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/201505/31/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2019
 
Bayer HealthCare LLC.