NDC 11822-7891 Ibuprofen

Ibuprofen

NDC Product Code 11822-7891

NDC CODE: 11822-7891

Proprietary Name: Ibuprofen 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Ibuprofen is used for the short-term treatment of mild to moderate pain in adults. When used with a narcotic (such as morphine) it may be used to treat moderate to severe pain. It is also used to reduce fever. This medication is a nonsteroidal anti-inflammatory drug (NSAID).

Product Characteristics

Color(s):
BROWN (C48332)
Shape: CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
117
Score: 1

NDC Code Structure

NDC 11822-7891-2

Package Description: 50 TABLET, COATED in 1 BOTTLE

NDC 11822-7891-5

Package Description: 100 TABLET, COATED in 1 BOTTLE

NDC 11822-7891-9

Package Description: 500 TABLET, COATED in 1 BOTTLE

NDC Product Information

Ibuprofen with NDC 11822-7891 is a a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Ibuprofen is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Rite Aid Corporation

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Ibuprofen 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 200 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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • 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.
  • 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: Rite Aid Corporation
Labeler Code: 11822
FDA Application Number: ANDA091239 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: ANDA - A product marketed under an approved Abbreviated 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: 06-01-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ibuprofen Product Label Images

Ibuprofen 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

Otc - Active Ingredient

ACTIVE INGREDIENT(S)Ibuprofen 200 mg (NSAID)** nonstreoidal anti-inflammatory drug

Inactive Ingredient

SILICON DIOXIDE CROSCARMELLOSE SODIUM FERRIC OXIDE RED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE STARCH, PREGELATINIZED CORN POLYVINYL ALCOHOL POLYETHYLENE GLYCOL

Otc - Purpose

PURPOSEPain reliever / fever reducer

Indications & Usage

USE(S)temporarily relieves minor aches and pains due to :

backache

headache

menstrual cramps

minor pain of arthritis

muscular aches

the common cold

toothache

temporarily reduces fever

Dosage & Administration

DIRECTIONSdo not take more than directed

the smallest effective dose should be used
adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1caplet, 2 caplets may be used

do not exceed 6 caplets in 24 hours, unless directed by a doctor.
Children under 12 years: ask a doctor

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Warnings

WARNINGSAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:
asthma (wheezing)

blisters

facial swelling

hives

rash

shock

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

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 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: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.

How Supplied

THIS PRODUCT IS SUPPLIED IN BOTTLES OF:BOTTLES OF 50,100 AND 50

* Please review the disclaimer below.