NDC 49314-0733 Unishield Back Pain Off

Acetaminophen, Caffeine, Magnesium Salicylate

NDC Product Code 49314-0733

NDC CODE: 49314-0733

Proprietary Name: Unishield Back Pain Off 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: Acetaminophen, Caffeine, Magnesium Salicylate 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
FR;2
Score: 1

NDC Code Structure

  • 49314 - Unishield

NDC 49314-0733-3

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

NDC Product Information

Unishield Back Pain Off with NDC 49314-0733 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Back Pain Off is acetaminophen, caffeine, magnesium salicylate. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Unishield

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.

Unishield Back Pain Off 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.

  • MAGNESIUM SALICYLATE 290 mg/1
  • CAFFEINE 50 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.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POVIDONE (UNII: FZ989GH94E)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: part343 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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 Back Pain Off Product Label Images

Unishield Back Pain Off 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 ingredients (in each tablet) Acetaminophen 250 mgCaffeine 50 mgMagnesium Salicylate (NSAID*) 290 mgmagnesium (total) 20 mg*nonsteroidal anti-inflammatory drug

Otc - Purpose

PurposePain reliever/fever reducerPain reliever aidAnalgesic

Indications & Usage

Usestemporarily relieves minor aches and pains associated with:

■ back pain ■ muscular aches

Warnings

WarningsReye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shockAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rashIf a skin or allergic reaction occurs, stop use and seek medical help right away.Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophen■ 3 or more alcoholic drinks every day while using this productStomach 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 directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Otc - Do Not Use

Do not use■ if you ever have had an allergic reaction to acetaminophen, salicylates (NSAIDs) or any other pain

relievers/ fever reducers
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ for more than 10 days unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if■ stomach bleeding warning applies to you■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease■ you are taking a diuretic■ you have a history of stomach problems such as heartburn

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ taking prescription drugs for gout, diabetes, or arthritis■ taking the blood thinning drug warfarin■ under a doctor’s care for any serious condition■ taking any other drug

Otc - When Using

When using this product do not exceed recommended dose

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■pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ ringing in the ears or loss of hearing occurs■ redness or swelling is present in the painful area■ any new symptoms appears

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use salicylates (NSAIDs) 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions■
do not use more than directed■ drink a full glass of water with each doseAdults and children: (12 years and older) Take 2 tablets with water every 6 hours while symptoms persist. Do not exceed 8 tablets in 24 hours or as directed by a doctor.Children under 12 years: Ask a doctor

Other Safety Information

Other information■ each dose contains 40 mg of magnesium■ read all product information before using■ store at room temperature 59º-86ºF (15º-30ºC)■ avoid excessive heat and humidity■ tamper evident sealed packets■ do not use any opened or torn packets

Inactive Ingredient

Inactive ingredientshypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Otc - Questions

Questions or comments? 800-480-5855

Unishield Back Pain-Off

UnishieldBack Pain-OffBack Pain Relief100 Tablets/2Tablets Per PacketAcetaminophen 250 mgCaffeine 50 mgMagnesium Salicylate (NSAID) 290 mgPull To OpenThis Package is for Households Without Young Children.• Relieves backaches, muscular aches & PainsExtra Strength Pasin ReliefFast Acting Advanced FormulaTamper Evident Unit Dose Packets

* Please review the disclaimer below.