Resfridol Antitussive (new)

Resfridol Antitussive (new)
SPL v2
SPL
SPL Set ID 2864cc43-2213-c970-e063-6394a90ac61e
Route
ORAL
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (200 mg)
Inactive Ingredients
Sucralose Water Sorbitol Anhydrous Citric Acid Fd&c Red No. 40 Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-31

Description

Active ingredients (in each 10 mL) Purposes Dextromethorphan HBr 5 mg ............................................................................ Cough suppressant Guaifenesin 200 mg........................................................................................... Expectorant


Medication Information

Description

Active ingredients (in each 10 mL) Purposes Dextromethorphan HBr 5 mg ............................................................................ Cough suppressant Guaifenesin 200 mg........................................................................................... Expectorant

Uses

Temporarily relieves common cold symptoms:

  • cough due to minor throat & bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to:
  • drain bronchial tubes
  • make coughs more productive
Section 55105-1
Active ingredients (in each 10 mL) Purposes
Dextromethorphan HBr 5 mg ............................................................................

Cough suppressant

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

Directions

■ only use the dosage cup provided

■ shake well before use

■ do not exceed 6 doses per 24-hour period

Age Dose
adults and children 12 years and older 20 mL, every 4 hours
children 6 to under 12 years 10 mL, every 4 hours
children under 6 years do not use

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.
Questions?

+1-809-544-0222

(M-F) 9 AM - 5 PM EST or www.laboratoriosalfa.com

Other Information

■ store between 68-77°F (20-25°C)

■ do not use if safety seal over cap is torn, broken, or missing

Inactive Ingredients

anhydrous citric acid, FD&C red #40, flavors, sodium benzoate, sorbitol, sucralose, water

Principal Display Panel

Stop Use and Ask A Doctor If

■ a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

■a cough that is accompanied by excessive phlegm (mucus)

■ a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema


Structured Label Content

Uses

Temporarily relieves common cold symptoms:

  • cough due to minor throat & bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to:
  • drain bronchial tubes
  • make coughs more productive
Section 55105-1 (55105-1)
Active ingredients (in each 10 mL) Purposes
Dextromethorphan HBr 5 mg ............................................................................

Cough suppressant

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

Directions

■ only use the dosage cup provided

■ shake well before use

■ do not exceed 6 doses per 24-hour period

Age Dose
adults and children 12 years and older 20 mL, every 4 hours
children 6 to under 12 years 10 mL, every 4 hours
children under 6 years do not use

Do Not Use (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.
Questions?

+1-809-544-0222

(M-F) 9 AM - 5 PM EST or www.laboratoriosalfa.com

Other Information (Other information)

■ store between 68-77°F (20-25°C)

■ do not use if safety seal over cap is torn, broken, or missing

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red #40, flavors, sodium benzoate, sorbitol, sucralose, water

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■a cough that is accompanied by excessive phlegm (mucus)

■ a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)