Giltuss Allergy Plus Cough & Congestion

SPL v6

SPL

SPL Set ID 85065cf3-386d-22d5-e053-2a91aa0a72da

Route

ORAL

Published

Effective Date 2019-03-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Propylparaben Methylparaben Glycerin Water Anhydrous Citric Acid Sucralose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-10-02

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 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

Do 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

adults and children 12 years and over	10 mL every 4 to 6 hours
children 6 to under 12 years	5 mL every 4 to 6 hours
children under 6 years	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, seek professional help or contact a Poison Control Center 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 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
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness effect
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking any other oral nasal decongestant or stimulant

Section 50569-3

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlargement of the prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1

Do not use

to sedate a child or to make a child sleepy
if 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

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

Section 51945-4

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE.

RELIEVES

SNEEZING
RUNNY NOSE
ITCHY AND WATERY EYES
COUGH
STUFFY NOSE
SINUS PRESSURE

TUTTI FRUTTI 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 breastfeeding, ask a health professional before use.

Section 55105-1

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Section 55106-9

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

Structured Label Content

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

Do 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

adults and children 12 years and over	10 mL every 4 to 6 hours
children 6 to under 12 years	5 mL every 4 to 6 hours
children under 6 years	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, seek professional help or contact a Poison Control Center 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 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
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness effect
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking any other oral nasal decongestant or stimulant

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 enlargement of the prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Section 50570-1 (50570-1)

Do not use

to sedate a child or to make a child sleepy
if 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

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

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss® ALLERGY PLUS COUGH & CONGESTION

ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE.

RELIEVES

SNEEZING
RUNNY NOSE
ITCHY AND WATERY EYES
COUGH
STUFFY NOSE
SINUS PRESSURE

TUTTI FRUTTI 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 breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 4 mg

Dextromethorphan HBr, USP 20 mg

Phenylephrine HCl, USP 10 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "34068-7": "Directions Do 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 adults and children 12 years and over 10 mL every 4 to 6 hours children 6 to under 12 years 5 mL every 4 to 6 hours children under 6 years Consult a Doctor", "34071-1": "Warnings", "42229-5": "Drug Facts", "44425-7": "Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS", "50565-1": "Keep out of reach of children. In case of overdose, seek professional help or contact a Poison Control Center right away.", "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 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.", "50567-7": "When using this product do not use more than directed may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness effect be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking any other oral nasal decongestant or stimulant", "50569-3": "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to enlargement of the prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema", "50570-1": "Do not use to sedate a child or to make a child sleepy if 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.", "51727-6": "Inactive ingredients citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose", "51945-4": "MAXIMUM STRENGTH Giltuss® ALLERGY PLUS COUGH & CONGESTION ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE. RELIEVES SNEEZING RUNNY NOSE ITCHY AND WATERY EYES COUGH STUFFY NOSE SINUS PRESSURE TUTTI FRUTTI FLAVOR 4FL OZ (118 mL)", "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.", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "55105-1": "Purposes Antihistamine Cough suppressant Nasal decongestant", "55106-9": "Active ingredients (in each 10 mL) Chlorpheniramine maleate, USP 4 mg Dextromethorphan HBr, USP 20 mg Phenylephrine HCl, USP 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:02.039337 · Updated: 2026-03-14T23:12:59.392851