giltuss children's allergy plus cough & congestion

giltuss children's allergy plus cough & congestion
SPL v6
SPL
SPL Set ID 852c5a57-7ee4-3c5c-e053-2a91aa0a1433
Route
oral
Published
Effective Date 2019-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorpheniramine (2 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
propylparaben methylparaben glycerin water anhydrous citric acid sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
otc monograph drug active Since 2018-11-07
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients (in each 5 mL)

Chlorpheniramine maleate USP, 2 mg

Dextromethorphan HBr USP, 10 mg

Phenylephrine HCl USP, 5 mg

Indications and Usage

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Dosage and Administration

Directions

  • not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • mL=milliter
children under 6 years Consult a Doctor
children 6 to under 12 years 5 mL every 4 to 6 hours
adults and children 12 years and over 10 mL every 4 to 6 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

  • nervousness, dizzyness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by a 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
  • may cause marked drowsiness
  • excitability may occur, especially in children
Section 50568-5

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking any other oral nasal decongestant or stimulant
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
Section 50570-1

Do not use

  • to sedate a child or to 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 taking this product.
Section 51727-6

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

Section 51945-4

Children's

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free.

  • SNEEZING
  • RUNNY NOSE
  • COUGH
  • ITCHY & WATERY EYES
  • STUFFY NOSE
  • SINUS PRESSURE

TUTTI FRUTTI 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 breastfeeding, ask a health professional before use.

Section 55105-1

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients (in each 5 mL)

Chlorpheniramine maleate USP, 2 mg

Dextromethorphan HBr USP, 10 mg

Phenylephrine HCl USP, 5 mg

Indications and Usage (34067-9)

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Dosage and Administration (34068-7)

Directions

  • not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • mL=milliter
children under 6 years Consult a Doctor
children 6 to under 12 years 5 mL every 4 to 6 hours
adults and children 12 years and over 10 mL every 4 to 6 hours
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

  • nervousness, dizzyness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by a 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
  • may cause marked drowsiness
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is

  • taking sedatives or tranquilizers
  • taking any other oral nasal decongestant or stimulant
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
Section 50570-1 (50570-1)

Do not use

  • to sedate a child or to 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 taking this product.
Section 51727-6 (51727-6)

Inactive ingredients

citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose

Section 51945-4 (51945-4)

Children's

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

Alcohol Free. Sodium Free. Sugar Free. Dye Free.

  • SNEEZING
  • RUNNY NOSE
  • COUGH
  • ITCHY & WATERY EYES
  • STUFFY NOSE
  • SINUS PRESSURE

TUTTI FRUTTI 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 breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:02.056334 · Updated: 2026-03-14T23:12:59.392851