ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent tablet, effervescent 
Select Corporation

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 Flu

Drug Facts

Active ingredients (in each tablet)Purposes
Acetaminophen 250 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan hydrobromide 10 mgCough suppressant
Phenylephrine hydrochloride 5 mgNasal decongestant

Uses

Warnings

Liver warning

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 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
  • 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

  • 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 a 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

anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack

Alka-
Seltzer
PLUS®

ACETAMINOPHEN / Pain Reliever-Fever Reducer
Chlorpheniramine Maleate / Antihistamine
Dextromethorphan HBr / Cough Suppressant
Phenylephrine Hydrochloride / Nasal Decongestant

SEVERE
Cold
& Flu
CITRUS

• Fever & Body Ache • Cough • Nasal Congestion
• Runny Nose • Sore Throat

BAYER

POWER FAST FiZZ™

2
EFFERVESCENT
Tablets
Single-Pack

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack
ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ 
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-830(NDC:0280-0022)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen250 mg
Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide10 mg
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride5 mg
Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine maleate2 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
anhydrous citric acid (UNII: XF417D3PSL)  
FD&C red no. 40 (UNII: WZB9127XOA)  
magnesium stearate (UNII: 70097M6I30)  
maltodextrin (UNII: 7CVR7L4A2D)  
mannitol (UNII: 3OWL53L36A)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITE (Speckled) Scoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;FLU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-830-041 in 1 BLISTER PACK07/03/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-830-052 in 1 BLISTER PACK07/03/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:52904-830-2020 in 1 CARTON07/03/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:52904-830-2525 in 1 CARTON07/03/2017
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:52904-830-3030 in 1 CARTON07/03/2017
52 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/03/2017
Labeler - Select Corporation (053805599)

Revised: 5/2022
Document Id: eda1d1c6-b5f4-4b40-89c5-ee0c44a78ee3
Set id: 00c4b91d-2edf-4090-9de3-7eac35d7428c
Version: 2
Effective Time: 20220512
 
Select Corporation