Adult Severe Congestion And Cough Multi-symptom

Adult Severe Congestion And Cough Multi-symptom
SPL v1
SPL
SPL Set ID 9072a1d8-5afc-4504-853b-5beef41e329e
Route
ORAL
Published
Effective Date 2013-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-12-01

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Uses
  • hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold
Section 50565-1



Warnings

Do not use

  • for children 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.

Directions
  • do not take more than 6 doses in 24-hour period
  • measure only with dosing coup provided
  • do not use dosing cup  with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years and older: 20 mL  in dosing cup provided every 4 hours
  • Children under 12 years of age: Do not use

Other Information
  • each 20 mL contains: sodium 20 mg
  • store between 15-30oC(59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

COMPARE TO MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH ACTIVE INGREDIENTS

adult severe congestion and cough

multi-symptom

Relieves nasal and chest congestion,

Soothes Cough,

Thins and loosens mucus

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorent

PHENYLEPHRINE HCl

Nasal decongestant,

For Ages 12 and Over

MAXIMUM STRENGTH

6 fl oz (177 mL)



When Using This Product
  • do not use more than directed

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with 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 overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg



Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)


Structured Label Content

Uses
  • hepls loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold
Section 50565-1 (50565-1)



Purpose

Cough suppressant

Expectorant

Nasal decongestant

Warnings

Do not use

  • for children 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.

Directions
  • do not take more than 6 doses in 24-hour period
  • measure only with dosing coup provided
  • do not use dosing cup  with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years and older: 20 mL  in dosing cup provided every 4 hours
  • Children under 12 years of age: Do not use

Other Information (Other information)
  • each 20 mL contains: sodium 20 mg
  • store between 15-30oC(59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, edetate disodium, FDand C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

COMPARE TO MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH ACTIVE INGREDIENTS

adult severe congestion and cough

multi-symptom

Relieves nasal and chest congestion,

Soothes Cough,

Thins and loosens mucus

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorent

PHENYLEPHRINE HCl

Nasal decongestant,

For Ages 12 and Over

MAXIMUM STRENGTH

6 fl oz (177 mL)



When Using This Product (When using this product)
  • do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with 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. In case of overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg



Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)


Advanced Ingredient Data


Raw Label Data

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