ADVIL DUAL ACTION WITH ACETAMINOPHEN- ibuprofen, acetaminophen tablet, film coated

ADVIL DUAL ACTION WITH ACETAMINOPHEN by

Drug Labeling and Warnings

ADVIL DUAL ACTION WITH ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet)	Purposes
* nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg	Pain reliever
Ibuprofen 125 mg (NSAID *)	Pain reliever

INDICATIONS & USAGE

Uses

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

WARNINGS

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:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • 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 during the last 3 months of 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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

Inactive ingredients

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVIL DUAL ACTION WITH ACETAMINOPHEN 
ibuprofen, acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-211(NDC:0573-0147)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	125 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	Advil;II
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-211-01	1 in 1 CARTON	05/21/2021
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-211-02	2 in 1 CARTON	05/21/2021
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA211733	05/21/2021

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-211) , repack(67751-211)