NDC 49314-0993 Unishield Ibuprofen

Ibuprofen

NDC Product Code 49314-0993

NDC CODE: 49314-0993

Proprietary Name: Unishield 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 to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Product Characteristics

Color(s):
BROWN (C48332 - REDDISH)
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
G;2
44;291
Score: 1

NDC Code Structure

  • 49314 - Unishield

NDC 49314-0993-3

Package Description: 50 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC Product Information

Unishield Ibuprofen with NDC 49314-0993 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Ibuprofen is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Unishield

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.

Unishield 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.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POVIDONE (UNII: FZ989GH94E)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • TALC (UNII: 7SEV7J4R1U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Unishield
Labeler Code: 49314
FDA Application Number: ANDA075010 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: 03-01-2021 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.

Unishield 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet) Ibuprofen 200 mg (NSAID*)*nonsteroidal anti-inflammatory drug

Otc - Purpose

PurposePain reliever/fever reducer

Indications & Usage

UsesTemporarily relieves minor aches and pains associated with■ headache ■ toothache ■ backache ■ menstrual cramps■ common cold ■ muscular aches ■ minor arthritis painTemporarily reduces fever.

Warnings

WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blistersIf 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 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 directedHeart 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.

Otc - Do Not Use

Do not use■ if you have ever had an allergic reaction to any other pain reliever/fever reducer■ right before or after heart surgery

Otc - Ask Doctor

Ask a doctor before use if■ you have problems or serious side effects from taking pain relievers or fever reducers■ stomach bleeding warning applies to you■ 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin■ under a doctor’s care for any serious condition■ taking any other drug

Otc - When Using

When using this product■ take with food or milk if stomach upset occurs

Otc - Stop Use

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 for more than 10 days■ fever gets worse or lasts for more than 3 days■ redness or swelling is present in the painful area■ any new or unexpected symptoms occur

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 specifically 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

Directions■
do not use more than directed■ the smallest effective dose should be used■ do not take longer than 10 days, unless directed by a doctor (see Warnings)Adults and children: (12 years and older)Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.

Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years:Ask a doctor.

Other Safety Information

Other information■ read all product information before using■ store at 68-77°F (20-25°C)■ avoid excessive heat 40°C (above 104°F)■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredient

Inactive ingredientscarnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide*may contain

Otc - Questions

Questions or comments? 800-480-5855

Unishield Ibuprofen Label

UnishieldIbuprofen 200 mgPain Reliever/Fever Reducer (NSAID)100 Tablets/ 1 Tablet Per PacketPull To OpenThis Package is for Households without Young Children.• Temporary relief from pain, fever and inflammation• Soothes muscle aches and minor arthritis painCompare active ingredient to:Advil®Registered Trademark of Pfizer Consumer HealthcareTamper Evident Unit Dose Packets

UnishieldIbuprofen 200 mgPain Reliever/Fever Reducer (NSAID)100 Tablets/ 1 Tablet Per PacketPull To OpenThis Package is for Households without Young Children.• Temporary relief from pain, fever and inflammation• Soothes muscle aches and minor arthritis painCompare active ingredient to:Advil®Registered Trademark of Pfizer Consumer HealthcareTamper Evident Unit Dose Packets

* Please review the disclaimer below.