Giltuss Children's Cough & Cold

Giltuss Children's Cough & Cold
SPL v6
SPL
SPL Set ID 852b77ae-a5ac-3ead-e053-2a91aa0a54bd
Route
ORAL
Published
Effective Date 2019-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg) Guaifenesin (150 mg) Phenylephrine (5 mg)
Inactive Ingredients
Water Polyethylene Glycol, Unspecified Sorbitol Sucralose Anhydrous Citric Acid Propylparaben Propylene Glycol Methylparaben Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-07
Description

Drug Facts

Medication Information

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
  • stuffy nose
Dosage and Administration

Directions

  • do not exceed recommended dosage
  • do not take more than 6 doses in any 24 hour period
  • keep dosing cup for use with this product
  • mL = milliliters
children under 2 years Consult a doctor
children 2 to under 6 years of age 1.25 mL every 4 hours
children 6 to 12 years of age 2.5 mL every 4 hours
children 12 years and over 5 mL every 4 hours

Description

Drug Facts

Section 42229-5

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
  • nervousness, dizziness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if the child is

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives, tranquilizers
Section 50569-3

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis
Section 50570-1

Do not use

  • to sedate a child or make a child sleepy
  • in a child who is 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 giving this product.
Section 51727-6

Inactive ingredients

citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

Section 51945-4

Children's

GILTUSS ®

COUGH & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

  • COUGH AND COLD
  • CHEST CONGESTION
  • STUFFY NOSE
  • NASAL CONGESTION
  • LOOSEN PHLEGM AND MUCUS
  • SINUS PRESSURE

CHERRY FLAVOR

4 FL 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 Suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
  • stuffy nose
Dosage and Administration (34068-7)

Directions

  • do not exceed recommended dosage
  • do not take more than 6 doses in any 24 hour period
  • keep dosing cup for use with this product
  • mL = milliliters
children under 2 years Consult a doctor
children 2 to under 6 years of age 1.25 mL every 4 hours
children 6 to 12 years of age 2.5 mL every 4 hours
children 12 years and over 5 mL every 4 hours

Section 42229-5 (42229-5)

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
  • nervousness, dizziness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is

  • taking any other oral nasal decongestant or stimulant
  • taking sedatives, tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis
Section 50570-1 (50570-1)

Do not use

  • to sedate a child or make a child sleepy
  • in a child who is 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 giving this product.
Section 51727-6 (51727-6)

Inactive ingredients

citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

Section 51945-4 (51945-4)

Children's

GILTUSS ®

COUGH & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

  • COUGH AND COLD
  • CHEST CONGESTION
  • STUFFY NOSE
  • NASAL CONGESTION
  • LOOSEN PHLEGM AND MUCUS
  • SINUS PRESSURE

CHERRY FLAVOR

4 FL 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 Suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:02.052749 · Updated: 2026-03-14T23:12:59.392851