ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution 
Bayer HealthCare LLC.

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Alka-Seltzer Plus ® Day Severe Cold+Flu

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 500 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine hydrochloride 10 mgNasal decongestant

Uses

Warnings

Liver warning

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

  • more than 6 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

  • 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

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, maltodextrin, povidone, pregelatinized starch, silicon dioxide, sodium citrate, stearic acid, sucralose, tartaric acid, tribasic calcium phosphate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

Alka-Seltzer PLUS ®

Severe Cold & Flu

Honey Lemon Zest

Fast Relief Mix-In Packets

Day NON-DROWSY

Acetaminophen / Pain reliever-fever reducer

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

• Nasal Congestion

• Headache
• Sore Throat

• Body Ache

• Cough
• Mucus

• Chest Congestion

• Fever

6 PACKETS

Carton 6

ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0921
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SUCROSE (UNII: C151H8M554)  
LEMON (UNII: 24RS0A988O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POVIDONE (UNII: FZ989GH94E)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TARTARIC ACID (UNII: W4888I119H)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HONEY (UNII: Y9H1V576FH)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorLEMON, HONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0921-066 in 1 CARTON04/17/201402/28/2020
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/17/2014
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp.968335112manufacture(0280-0921)

Revised: 1/2024
Document Id: 0e885b70-a708-5d10-e063-6294a90a1a99
Set id: cec51eab-cce3-4965-a14e-a46d953050c4
Version: 10
Effective Time: 20240109
 
Bayer HealthCare LLC.