Alka-Seltzer Plus Day Severe Cold, Cough And Flu

Dosage form: powder
Ingredients: Acetaminophen 650mg, Dextromethorphan hydrobromide 20mg, Phenylephrine hydrochloride 10mg
Labeler: Bayer HealthCare LLC - Consumer Care
NDC Code: 0280-1155

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 Severe Cold, Cough & Flu

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Phenylephrine hydrochloride 10 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 5 packets 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
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • 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
  • a sodium-restricted diet

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
  • take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
  • adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • children under 12 years: do not use
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information
  • each packet contains: potassium 5 mg and sodium 41 mg
  • Phenylketonurics: Contains Phenylalanine 17 mg Per Packet
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, FD&C blue #1, FD&C red #40, flavor, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NEW!
Mix-In Packets

Alka-
Seltzer
PLUS
®
Acetaminophen / Pain
reliever-fever reducer
Phenylephrine HCl / Nasal decongestant
Dextromethorphan hydrobromide /
Cough suppressant

Berry Fusion
Fast Relief Mix-In Packets

DAY
SEVERE
COLD, COUGH & FLU

Nasal Congestion • Cough
Headache + Body Ache • Sore Throat

6 PACKETS

ALKA-SELTZER PLUS DAY SEVERE COLD, COUGH AND FLU 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1155
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen650 mg
Dextromethorphan hydrobromide (Dextromethorphan) Dextromethorphan hydrobromide20 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C Red No. 40 
Acesulfame potassium 
anhydrous citric acid 
aspartame 
silicon dioxide 
FD&C blue No. 1 
maltodextrin 
sodium citrate 
sucrose 
tribasic calcium phosphate 
Product Characteristics
ColorWHITE (white, red and dark particles) Score    
ShapeSize
FlavorBERRY (Berry Fusion) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-1155-066 PACKET in 1 CARTON
11 POWDER in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34307/31/2012
Labeler - Bayer HealthCare LLC - Consumer Care (785159372)

Revised: 06/2012
 
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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