Giltuss Multi-symptom Cold & Flu

SPL v6

SPL

SPL Set ID 8518fd91-981e-de78-e053-2a91aa0afcb2

Route

ORAL

Published

Effective Date 2019-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Phenylephrine (10 mg) Dextromethorphan (13 mg) Acetaminophen (650 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Anhydrous Citric Acid Propylparaben Glycerin Propylene Glycol Water Sucralose Edetic Acid Methylparaben

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

Liver warning:This product contains acetaminophen. Severe liver damage may occur if:

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash
hives
facial swelling
asthma (wheezing)
shock

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

Uses

temporarily relieves:
minor aches and pains
headache
minor sore throat pain
runny nose
itchy nose or throat
sneezing
itchy watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold
temporarily reduces fever

Dosage and Administration

Directions

do not give more than directed
use enclosed dosing cup
keep dosing cup for use with this product
mL = milliliter

adults and children 12 years and over	10 mL every 4-6 hours, not to exceed 6 doses in 2 hours
children 6 to under 12 years of age	5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
children under 6 years of age	Do not use

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

you get nervousness, dizzyness or sleeplessness
pain, nasal congestion, or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7

When using this product

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3

Ask a doctor or pharmacist before use if the user has

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

Section 50570-1

Do not use

if you are allergic to acetaminophen or any inactive ingredient in this product
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose

Section 51945-4

MAXIMUM STRENGTH

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE

RELIEVES

FEVER, HEADACHE AND BODY ACHES
COUGH AND COLD
SNEEZING
RUNNY NOSE
ITCHY AND WATERY EYES
STUFFY NOSE
SINUS PRESSURE

STRAWBERRY 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

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Section 55106-9

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan hydrobromide 13 mg

Phenylephrine hydrochloride 10 mg

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves:
minor aches and pains
headache
minor sore throat pain
runny nose
itchy nose or throat
sneezing
itchy watery eyes due to hay fever
nasal and sinus congestion
cough due to minor throat and bronchial irritation as may occur with a cold
temporarily reduces fever

Dosage and Administration (34068-7)

Directions

do not give more than directed
use enclosed dosing cup
keep dosing cup for use with this product
mL = milliliter

adults and children 12 years and over	10 mL every 4-6 hours, not to exceed 6 doses in 2 hours
children 6 to under 12 years of age	5 mL every 4-6 hours, not to exceed 5 doses in 24 hours
children under 6 years of age	Do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if:

adult takes more than 6 doses in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash
hives
facial swelling
asthma (wheezing)
shock

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you get nervousness, dizzyness or sleeplessness
pain, nasal congestion, or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

do not exceed recommended dosage
marked drowsiness may occur
excitability may occur, especially in children
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor or pharmacist before use if the user has

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

Section 50570-1 (50570-1)

Do not use

if you are allergic to acetaminophen or any inactive ingredient in this product
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss® MULTI-SYMPTOM

COLD & FLU

ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT

ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE

RELIEVES

FEVER, HEADACHE AND BODY ACHES
COUGH AND COLD
SNEEZING
RUNNY NOSE
ITCHY AND WATERY EYES
STUFFY NOSE
SINUS PRESSURE

STRAWBERRY 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

Pain reliever/fever reducer

Antihistamine

Cough Suppressant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Acetaminophen 650 mg

Chlorpheniramine maleate 4 mg

Dextromethorphan hydrobromide 13 mg

Phenylephrine hydrochloride 10 mg

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "13", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves: minor aches and pains headache minor sore throat pain runny nose itchy nose or throat sneezing itchy watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold temporarily reduces fever", "34068-7": "Directions do not give more than directed use enclosed dosing cup keep dosing cup for use with this product mL = milliliter adults and children 12 years and over 10 mL every 4-6 hours, not to exceed 6 doses in 2 hours children 6 to under 12 years of age 5 mL every 4-6 hours, not to exceed 5 doses in 24 hours children under 6 years of age Do not use", "34071-1": "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50566-9": "Stop use and ask a doctor if you get nervousness, dizzyness or sleeplessness pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.", "50567-7": "When using this product do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery", "50568-5": "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin taking sedatives or tranquilizers", "50569-3": "Ask a doctor or pharmacist before use if the user has liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) chronic cough that lasts such as occurs with smoking, asthma, or emphysema trouble urinating due to enlargement of the prostate gland", "50570-1": "Do not use if you are allergic to acetaminophen or any inactive ingredient in this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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, disodium EDTA, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water and sucralose", "51945-4": "MAXIMUM STRENGTH Giltuss® MULTI-SYMPTOM COLD & FLU ANALGESIC, ANTITUSSIVE, ANTIHISTAMINE & NASAL DECONGESTANT ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE RELIEVES FEVER, HEADACHE AND BODY ACHES COUGH AND COLD SNEEZING RUNNY NOSE ITCHY AND WATERY EYES STUFFY NOSE SINUS PRESSURE STRAWBERRY 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 breast-feeding , ask a health professional before use.", "55105-1": "Purposes Pain reliever/fever reducer Antihistamine Cough Suppressant Nasal decongestant", "55106-9": "Active ingredients (in each 10 mL) Acetaminophen 650 mg Chlorpheniramine maleate 4 mg Dextromethorphan hydrobromide 13 mg Phenylephrine hydrochloride 10 mg", "60561-8": "Other information store at room temperature 15° - 30°C (59° - 86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:02.048142 · Updated: 2026-03-14T23:12:59.392851