Advil Multi-Symptom Cold and Flu

Manufacturer
Haleon US Holdings LLC | PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
Effective date
2025-10-03
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:15:48

Key Label Information#

Active Ingredients And Purpose

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

Purposes

Antihistamine Pain reliever/Fever reducer Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever minor body aches and pains nasal congestion runny nose sinus pressure sneezing reduces swelling of the nasal passages temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Warnings

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed adults and children 12 years of age and over: take 1 tablet every 4 hours while symptoms persist do not take more than 6 tablets in any 24-hour period, unless directed by a doctor children under 12 years of age: do not use

Other Label Information

STORAGE AND HANDLING SECTION

Other information read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

PRINCIPAL DISPLAY PANEL

Advil MULTI-SYMPTOM COLD & FLU Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Phenylephrine HCl 10 mg Nasal Decongestant Chlorpheniramine Maleate 4 mg Antihistamine Headache Fever Body Aches Sinus Pressure Nasal Congestion Runny Nose Sneezing Nasal Swelling ONE TABLET DOSE! 30 Coated Tablets 000065883 Carton

Label Images#

image-01
image-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN14
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD14

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0190-01Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-01Advil Multi-Symptom Cold and Flu50 in 1 TRAYTABLET, COATED5014
0573-0190-02Advil Multi-Symptom Cold and Flu2 in 1 CARTONTABLET, COATED214
0573-0190-02Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-03Advil Multi-Symptom Cold and Flu1 in 1 POUCHTABLET, COATED114
0573-0190-03Advil Multi-Symptom Cold and Flu3000 in 1 CASETABLET, COATED300014
0573-0190-10Advil Multi-Symptom Cold and Flu1 in 1 CARTONTABLET, COATED114
0573-0190-10Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-20Advil Multi-Symptom Cold and Flu2 in 1 CARTONTABLET, COATED214
0573-0190-20Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-30Advil Multi-Symptom Cold and Flu10 in 1 BLISTER PACKTABLET, COATED1014
0573-0190-30Advil Multi-Symptom Cold and Flu3 in 1 CARTONTABLET, COATED314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0190-01EA - Each0573-019039b9c0f2-4011-4ec7-bde8-3375d2810b3b12022-06-06
0573-0190-10EA - Each0573-0190d6a5ce79-edd1-49f2-be81-9652fc874f6112020-07-13
0573-0190-20EA - Each0573-01903de50adc-b436-4fb7-8162-9c6d7968000212020-07-13

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-01900573-0190-10, 0573-0190-20, 0573-0190-01, 0573-0190-30, 0573-0190-03, 0573-0190-02

Ingredients#

Complete SPL Sections#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Antihistamine Pain reliever/Fever reducer Nasal decongestant

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms associated with the common cold or flu: headache fever minor body aches and pains nasal congestion runny nose sinus pressure sneezing reduces swelling of the nasal passages temporarily restores freer breathing through the nose

WARNINGS SECTION

WARNINGS SECTION

Warnings

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed adults and children 12 years of age and over: take 1 tablet every 4 hours while symptoms persist do not take more than 6 tablets in any 24-hour period, unless directed by a doctor children under 12 years of age: do not use

STORAGE AND HANDLING SECTION

STORAGE AND HANDLING SECTION

Other information read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 For most recent product information, visit www.advil.com Trademarks owned or licensed by GSK ©2021 GSK or licensor

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil MULTI-SYMPTOM COLD & FLU Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID) Phenylephrine HCl 10 mg Nasal Decongestant Chlorpheniramine Maleate 4 mg Antihistamine Headache Fever Body Aches Sinus Pressure Nasal Congestion Runny Nose Sneezing Nasal Swelling ONE TABLET DOSE! 30 Coated Tablets 000065883 Carton

Source Document#

Source XML