NDC 67751-211 Advil Dual Action With Acetaminophen

Ibuprofen, Acetaminophen

NDC Product Code 67751-211

NDC CODE: 67751-211

Proprietary Name: Advil Dual Action With Acetaminophen What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ibuprofen, Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
15 MM
Imprint(s):
ADVIL;II
Score: 1

NDC Code Structure

  • 67751 - Navajo Manufacturing Company Inc.
    • 67751-211 - Advil Dual Action With Acetaminophen

NDC 67751-211-01

Package Description: 1 POUCH in 1 CARTON > 2 TABLET, FILM COATED in 1 POUCH

NDC Product Information

Advil Dual Action With Acetaminophen with NDC 67751-211 is a a human over the counter drug product labeled by Navajo Manufacturing Company Inc.. The generic name of Advil Dual Action With Acetaminophen is ibuprofen, acetaminophen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Navajo Manufacturing Company Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Advil Dual Action With Acetaminophen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • IBUPROFEN 125 mg/1
  • ACETAMINOPHEN 250 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Navajo Manufacturing Company Inc.
Labeler Code: 67751
FDA Application Number: NDA211733 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-21-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Advil Dual Action With Acetaminophen Product Label Images

Advil Dual Action With Acetaminophen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

  • Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
  • Skin reddeningblistersrashIf 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:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.

Otc - Purpose

Active ingredients (in each caplet)PurposesAcetaminophen 250 mgPain relieverIbuprofen 125 mg (NSAID
nonsteroidal anti-inflammatory drug)
Pain reliever

Indications & Usage

  • Usestemporarily relieves minor aches and pains due to:
  • Headachetoothachebackachemenstrual crampsmuscular achesminor 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 acetaminophenmore than 6 caplets in 24 hours, which is the maximum daily amount for this product3 or more alcoholic drinks every day while using this product

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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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 pharmacistif you have ever had an allergic reaction to acetaminophen or any other pain relieverright before or after heart surgery

Ask A Doctor Before Use If

  • You have liver diseasestomach bleeding warning applies to youyou have problems or serious side effects from taking pain relieversyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor's care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:
  • Chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysredness or swelling is present in the painful areaany new symptoms appear

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsdo not take more than directedadults and children 12 years and overtake 2 caplets every 8 hours while symptoms persist
  • Children under 12 yearsask a doctordo not take more than 6 caplets in 24 hours, unless directed by a doctor

Storage And Handling

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

Otc - Questions

Questions or comments?call weekdays 9 AM to 5 PM at
1-800-88-ADVIL

* Please review the disclaimer below.