Skip to Content

Alka-Seltzer Plus Severe Sinus and Cold

Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 650mg, CHLORPHENIRAMINE MALEATE 4mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-0923

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 ® Severe Sinus & Cold Powder

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Chlorpheniramine maleate 4 mgAntihistamine
Dextromethorphan hydrobromide 20 mgCough suppressant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold:
    • nasal congestion
    • sinus congestion and pressure
    • minor aches and pains
    • headache
    • cough
    • sore throat
  • temporarily restores freer breathing through the nose
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily reduces fever
  • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes

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 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
  • 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

Other information
  • each packet contains: potassium 5 mg and sodium 6 mg
  • store at room temperature

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, dental-type silica, FD&C blue #1, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

Alka-
Seltzer
PLUS
®

Acetaminophen / Pain
reliever-fever reducer
Chlorpheniramine maleate / Antihistamine
Phenylephrine HCI / Nasal decongestant
Dextromethorphan HBr / Cough
suppressant

Berry Fusion
Fast Relief Mix-In Packets

SEVERE
SINUS &
COLD

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

BAYER

6 PACKETS

ALKA-SELTZER PLUS SEVERE SINUS AND COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0923
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
SODIUM CITRATE 
SUCRALOSE 
TARTARIC ACID 
TRIBASIC CALCIUM PHOSPHATE 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-0923-066 PACKET in 1 CARTON
11 POWDER, FOR SOLUTION in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/17/201407/31/2018
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968335112manufacture(0280-0923), pack(0280-0923)

Revised: 12/2017
 
Bayer HealthCare LLC.

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.

Hide