Acetaflu Cough & Chest Congestion

Acetaflu Cough & Chest Congestion
SPL v1
SPL
SPL Set ID 5a6c9b52-255b-48d9-b92e-ded3aa9e29d4
Route
ORAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Lactose Monohydrate Maltodextrin Mannitol Povidone K30 Silicon Dioxide Sodium Bicarbonate Sodium Chloride Sodium Citrate Sucralose Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-31

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  •  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 51945-4

Purposes
  • Cough suppressant
  • Expectorant
Warnings

Do not use

  •  in a child under 12 years of age
  •  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.

Ask a doctor before use if you have

  •  cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a sodium-restricted diet

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

  • ask a health care professional before use.
Directions



do not use more than directed

take every 4 hours. Do not take more than 6 packets in 24 hours.

Age Dose
adults and children 12 years of age and over   one packet
 children under 12 years of age do not use 
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. 
  • Do not overheat.
Other Information



  •  each packet contains: potassium 12 mg, sodium 51 mg.
  • store at controlled room temperature 20-25°C (68-77°F).
Active Ingredients

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Inactive Ingredients.

acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  •  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Section 51945-4 (51945-4)

Purposes
  • Cough suppressant
  • Expectorant
Warnings

Do not use

  •  in a child under 12 years of age
  •  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.

Ask a doctor before use if you have

  •  cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a sodium-restricted diet

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

  • ask a health care professional before use.
Directions



do not use more than directed

take every 4 hours. Do not take more than 6 packets in 24 hours.

Age Dose
adults and children 12 years of age and over   one packet
 children under 12 years of age do not use 
  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. 
  • Do not overheat.
Other Information (Other information)



  •  each packet contains: potassium 12 mg, sodium 51 mg.
  • store at controlled room temperature 20-25°C (68-77°F).
Active Ingredients

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Inactive Ingredients.

acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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