ADVIL DUAL ACTION WITH ACETAMINOPHEN- ibuprofen, acetaminophen tablet, film coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Uses

temporarily relieves minor aches and pains due to:
o
headache
o
toothache
o
backache
o
menstrual cramps
o
muscular aches
o
minor pain of arthritis

Warnings

Acetaminophen liver damage warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

with other drugs containing acetaminophen
more than 6 caplets in 24 hours, which is the maximum daily amount for this product
3 or more alcoholic drinks every day while using this product

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

skin reddening
blisters
rash

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

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

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

If an allergic reaction occurs, stop use and seek medical help right away.

NSAID stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Heart attack and stroke warning:

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

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 have ever had an allergic reaction to acetaminophen or any other pain reliever
right before or after heart surgery

Ask a doctor before use if

you have liver disease
stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

When using this product

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
o
feel faint
o
vomit blood
o
have bloody or black stools
o
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
o
chest pain
o
trouble breathing
o
weakness in one part or side of body
o
slurred speech
o
leg swelling
pain gets worse or lasts more than 10 days
redness or swelling is present in the painful area
any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed

adults and children

12 years and over

take 2 caplets every 8 hours while symptoms persist

children under 12 years

ask a doctor
do not take more than 6 caplets in 24 hours, unless directed by a doctor

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 ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions or comments?

call weekdays 9 AM to 5 PM at 1-800-88-ADVIL

PRINCIPAL DISPLAY PANEL

NDC 0573-0147-94
Advil
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

144
Caplets*
*Capsule-Shaped Tablets

000067297 Front Carton

Advil Dual Action Capsule-Shaped Tablets 144ct Carton
ADVIL DUAL ACTION WITH ACETAMINOPHEN 
ibuprofen, acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0147
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN125 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil;II
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0147-181 in 1 CARTON07/27/2020
118 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0147-361 in 1 CARTON07/27/2020
236 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0147-721 in 1 CARTON07/27/2020
372 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0147-861 in 1 CARTON07/27/2020
4216 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0147-941 in 1 CARTON07/27/2020
5144 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0147-9550 in 1 CARTON07/27/2020
62 in 1 POUCH; Type 0: Not a Combination Product
7NDC:0573-0147-098 in 1 BOTTLE; Type 0: Not a Combination Product05/15/2023
8NDC:0573-0147-913000 in 1 CASE05/15/2023
82 in 1 POUCH; Type 0: Not a Combination Product
9NDC:0573-0147-931 in 1 CARTON04/09/2024
9162 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0573-0147-901 in 1 CARTON04/08/2024
1090 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21173307/27/2020
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: f260d9a3-e69f-4a8e-9014-256bb65e2ee2
Set id: f5ea858e-76d9-4777-b3dc-5d614f66d485
Version: 9
Effective Time: 20240424
 
Haleon US Holdings LLC