OTC Medication Information: ADVIL DUAL ACTION WITH ACETAMINOPHEN

ADVIL DUAL ACTION WITH ACETAMINOPHEN- ibuprofen and acetaminophen tablet, film coated
Navajo Manufacturing Company Inc.

Drug Facts

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

Uses

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

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

Advil Dual Action
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 125 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
GLYCERYL DIBEHENATE
HYPROMELLOSE, UNSPECIFIED
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15mm
Flavor Imprint Code Advil;II
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67751-211-01 1 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (67751-211-01)
2 NDC:67751-211-02 2 POUCH in 1 CARTON contains a POUCH
2 2 TABLET, FILM COATED in 1 POUCH This package is contained within the CARTON (67751-211-02)
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 Operations
Navajo Manufacturing Company Inc. 136941411 relabel (67751-211), repack (67751-211)

Revised: 07/2022 Navajo Manufacturing Company Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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