Childrens Giltuss Honey Cough & Chest Congestion

Childrens Giltuss Honey Cough & Chest Congestion
SPL v6
SPL
SPL Set ID a8c052d8-fb9f-09f2-e053-2a95a90a37af
Route
ORAL
Published
Effective Date 2020-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Dextromethorphan (10 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
    children under 4 years Consult a doctor
    children 4 to under 6 years 2.5 mL every 4 hours
    children 6 to under 12 years 5 mL every 4 hours
    children 12 years and over 10 mL every 4 hours
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 if the child hasa cough 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 the child has

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

Do not useif your child is 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 child's 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

Children 4-12

Children's Giltuss®

Honey Cough & Chest Congestion

Made with real honey

Alcohol Free, Dye Free, Non Drowsy

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 55105-1

Purposes

Cough Suppressant

Expectorant

Section 55106-9

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 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
    children under 4 years Consult a doctor
    children 4 to under 6 years 2.5 mL every 4 hours
    children 6 to under 12 years 5 mL every 4 hours
    children 12 years and over 10 mL every 4 hours
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 if the child hasa cough 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 the child has

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

Do not useif your child is 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 child's 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)

Children 4-12

Children's Giltuss®

Honey Cough & Chest Congestion

Made with real honey

Alcohol Free, Dye Free, Non Drowsy

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 55105-1 (55105-1)

Purposes

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg


Advanced Ingredient Data


Raw Label Data

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