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

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Alka-Seltzer Plus ® Cold Medicine Sparkling Original

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 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
  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

  • each tablet contains: potassium 80 mg; sodium 356 mg
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

anhydrous citric acid, calcium silicate, dimethicone, FDC red #40, FDC yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povioone, sodium bicarbonate, sucralose.

Questions or comments?
1-800-986-0369 (Mon-Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

Alka-
Seltzer
PLUS ®

Acetaminophen / Pain reliever/fever reducer
Chlorpheniramine maleate / Antihistamine
Dextromethorphan hydrobromide / Cough suppressant
Phenylephrine hydrochloride / Nasal decongestant

COLD
FORMULA

SPARKLING
ORIGINAL

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

image description

ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ 
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70264-016(NDC:0280-0022)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
Colorwhite (Speckled) Scoreno score
ShapeROUNDSize25mm
FlavorImprint Code ASP;FLU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70264-016-0130 in 1 CARTON03/16/2023
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/16/2023
Labeler - R J General Corporation (122542830)
Establishment
NameAddressID/FEIBusiness Operations
R J General Corporation122542830repack(70264-016)

Revised: 10/2023
Document Id: 07cf16fa-4aed-5be5-e063-6294a90a4350
Set id: d786ae07-ce57-44c7-9ba5-f4c87df115de
Version: 2
Effective Time: 20231016
 
R J General Corporation