Alka-seltzer Plus Severe Cold & Cough Powerfast Fizz Effervescent Tablets

Alka-seltzer Plus Severe Cold & Cough Powerfast Fizz Effervescent Tablets
SPL v12
SPL
SPL Set ID a32e2a5e-9aa0-4e7c-e053-2995a90a3190
Route
ORAL
Published
Effective Date 2022-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Calcium Silicate Dimethicone Anhydrous Citric Acid Povidone Potassium Bicarbonate Sucralose Sodium Bicarbonate Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: ASP;CandC Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-05

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Do not use

● 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

● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Description

Drug Facts

Uses

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • the intensity of coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 51727-6

anhydrous citric acid, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium bicarbonate, sucralose

Section 55106-9

Active ingredients (in each tablet) Purposes

Dextromethorphan hydrobromide 10 mg………….…Cough suppressant

Guaifenesin 200 mg.......…………….….................................Expectorant

Section 60561-8

Other information

● each tablet contains: potassium 80 mg; sodium 237 mg

● store at room temperature. Avoid excessive heat.

Directions

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 12 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Carton 24 Count

Alka Seltzer Plus Maximum Strength Cough & Chest Congestion

POWERFAST FIZZ™

Dextromethorphan HBr / Cough Suppressant

Guaifenesin/Expectorant

24 EFFERVESCENT TABLETS

Questions Or Comments

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


Structured Label Content

Uses

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • the intensity of coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings and Precautions (34071-1)

Warnings

Do not use

● 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

● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

anhydrous citric acid, flavors, magnesium stearate, mannitol, potassium bicarbonate, sodium bicarbonate, sucralose

Section 55106-9 (55106-9)

Active ingredients (in each tablet) Purposes

Dextromethorphan hydrobromide 10 mg………….…Cough suppressant

Guaifenesin 200 mg.......…………….….................................Expectorant

Section 60561-8 (60561-8)

Other information

● each tablet contains: potassium 80 mg; sodium 237 mg

● store at room temperature. Avoid excessive heat.

Directions

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 12 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use
Carton 24 Count (Carton 24 count)

Alka Seltzer Plus Maximum Strength Cough & Chest Congestion

POWERFAST FIZZ™

Dextromethorphan HBr / Cough Suppressant

Guaifenesin/Expectorant

24 EFFERVESCENT TABLETS

Questions Or Comments (Questions or comments)

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


Advanced Ingredient Data


Raw Label Data

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