Robitussin ®

Robitussin ®
SPL v7
SPL
SPL Set ID caefc641-8470-4154-98a6-c0786071414e
Route
ORAL
Published
Effective Date 2021-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Propylene Glycol Saccharin Sodium Sodium Benzoate Sorbitol Water

Identifiers & Packaging

Marketing Status
EXPORT ONLY Active Since 2015-07-01

Description

Active ingredients (in each 5 mL tsp) Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant Pseudoephedrine HCl, USP 30 mg Nasal decongestant


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
Dosage and Administration

Directions

  • do not take more than 4 doses in any 24-hour period
age dose

adults and children 12 years and over

2 teaspoonfuls every 4 hours

children 6 years to under 12 years

1 teaspoonful every 4 hours

under 6 years

Do not use

Description

Active ingredients (in each 5 mL tsp) Purpose Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant Pseudoephedrine HCl, USP 30 mg Nasal decongestant

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • dosage cup provided
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help right away.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7

When using this product do not use more than directed.

Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 50570-1

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOl, ask a doctor or pharmacist before taking this product.

Section 51727-6

Inactive ingredients

citric acid, FD&C red no. 40, flavors, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Section 53413-1

MADE IN U.S.A.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL tsp) Purpose

Dextromethorphan HBr, USP 10 mg

Cough suppressant

Guaifenesin, USP 100 mg

Expectorant

Pseudoephedrine HCl, USP 30 mg

Nasal decongestant

Principal Display Panel 118 Ml Bottle Carton

Wyeth ®

Robitussin ®

CF

NASAL DECONGESTANT

COUGH SUPPRESSANT

EXPECTORANT

  • CLEARS

    NASAL STUFFINESS
  • CONTROLS COUGHS
  • LOOSENS and RELIEVES

    CHEST CONGESTION

COUGH FORMULA

For Children and Adults

4 FL OZ (118 mL)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • cough due to minor throat and bronchial irritation
Dosage and Administration (34068-7)

Directions

  • do not take more than 4 doses in any 24-hour period
age dose

adults and children 12 years and over

2 teaspoonfuls every 4 hours

children 6 years to under 12 years

1 teaspoonful every 4 hours

under 6 years

Do not use

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • dosage cup provided
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 50570-1 (50570-1)

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOl, ask a doctor or pharmacist before taking this product.

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C red no. 40, flavors, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Section 53413-1 (53413-1)

MADE IN U.S.A.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL tsp) Purpose

Dextromethorphan HBr, USP 10 mg

Cough suppressant

Guaifenesin, USP 100 mg

Expectorant

Pseudoephedrine HCl, USP 30 mg

Nasal decongestant

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

Wyeth ®

Robitussin ®

CF

NASAL DECONGESTANT

COUGH SUPPRESSANT

EXPECTORANT

  • CLEARS

    NASAL STUFFINESS
  • CONTROLS COUGHS
  • LOOSENS and RELIEVES

    CHEST CONGESTION

COUGH FORMULA

For Children and Adults

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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