Alka-Seltzer Plus Severe Cold & Flu Effervescent Tablets

Alka-Seltzer Plus Severe Cold & Flu Effervescent Tablets

Drug Labeling and Warnings

Drug Details

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ALKA-SELTZER PLUS SEVERE COLD AND FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, effervescent 
Bayer HealthCare LLC.

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 & Flu Effervescent Tablets

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · runny nose · sneezing

· nasal and sinus congestion

· temporarily reduces fever

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: sodium 416 mg

● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● store at room temperature. Avoid excessive heat.

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C red #40, flavors, magnesium stearate, maltodextrin, mannitol, saccharin sodium, sodium bicarbonate

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

Alka-Seltzer

PLUS®

SEVERE

Cold

& Flu

CITRUS

Acetaminophen / Pain Reliever-Fever Reducer

Chlorpheniramine Maleate / Antihistamine

Dextromethorphan HBr / Cough Suppressant

Phenylephrine Hydrochloride / Nasal Decongestant

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

20 EFFERVESCENT TABLETS

Carton 20 count

ALKA-SELTZER PLUS SEVERE COLD AND FLU 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0280-1560
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 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
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;FLU
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0280-1560-2010 in 1 CARTON07/03/2017
12 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 - Bayer HealthCare LLC. (112117283)

Revised: 9/2018
 
Bayer HealthCare LLC.


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