Giltuss Honey Cough & Chest Congestion

Giltuss Honey Cough & Chest Congestion
SPL v6
SPL
SPL Set ID a8b2c847-25e9-8714-e053-2995a90a73ce
Route
ORAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Water Glycerin Propylene Glycol Sucralose Anhydrous Citric Acid Honey Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-22

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosinc cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over 10 mL every 4 hours
    children 6 to under 12 years of age 5 mL every 4 hours
    children 4 to under 6 years of age 2.5 mL every 4 hours
    children under 4 years of age Consult a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE 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 50566-9

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

Section 50569-3

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 50570-1

Do not useif 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.

Section 51727-6

Inactive ingredients carboxymethycellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water, sucralose.

Section 51945-4

MAXIMUM STRENGTH

Giltuss®

Honey Cough & Chest Congestion

Made with real honey

ALCOHOL FREE. DYE FREE. NON-DROWSY

RELIEVES

COUGH AND COLD

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

HONEY LEMON FLAVOR

4FL OZ (118 mL)

Section 53413-1

Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9

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

Section 55105-1

Purposes

Cough Suppresant

Expectorant

Section 55106-9

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosinc cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over 10 mL every 4 hours
    children 6 to under 12 years of age 5 mL every 4 hours
    children 4 to under 6 years of age 2.5 mL every 4 hours
    children under 4 years of age Consult a doctor
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE 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 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough 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 (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.

Section 51727-6 (51727-6)

Inactive ingredients carboxymethycellulose sodium, citric acid, glycerin, natural and artificial flavor, natural grade A honey, methylparaben, propylene glycol, propylparaben, purified water, sucralose.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss®

Honey Cough & Chest Congestion

Made with real honey

ALCOHOL FREE. DYE FREE. NON-DROWSY

RELIEVES

COUGH AND COLD

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

HONEY LEMON FLAVOR

4FL OZ (118 mL)

Section 53413-1 (53413-1)

Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough Suppresant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg


Advanced Ingredient Data


Raw Label Data

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