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  5. Label Information: Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz

FDA Label for Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING:
    5. ALLERGY ALERT:
    6. OTC - DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL - 60 TABLET CARTON

Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz Product Label

The following document was submitted to the FDA by the labeler of this product R J General Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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



  • temporarily relieves these symptoms due to a cold or flu:
  • temporarily reduces fever

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.


Otc - Do Not Use



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

Otc - Pregnancy Or Breast Feeding



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.


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

image description - alka seltzer


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