Unishield Back Pain Off

Manufacturer
Unishield | Unifirst First Aid Corporation
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:36:05

Label at a glance#

ProductUnishield Back Pain Off
Active ingredientMAGNESIUM SALICYLATE, CAFFEINE, ACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetaminophen 250 mg

Caffeine 50 mg

Magnesium Salicylate (NSAID*) 290 mg

magnesium (total) 20 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Pain reliever aid

Analgesic

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains associated with:
■ back pain ■ muscular aches

WARNINGS SECTION

Warnings

Reye'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) ■ shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If 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 product

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

Caffeine 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 SECTION

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 SECTION

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 SECTION

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 SECTION

When using this product do not exceed recommended dose

OTC - STOP USE SECTION

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 SECTION

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 SECTION

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 SECTION

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

Adults 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 SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments? 800-480-5855

Unishield Back Pain-Off

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unishield

Back Pain-Off

Back Pain Relief

100 Tablets/2Tablets Per Packet

Acetaminophen 250 mg

Caffeine 50 mg

Magnesium Salicylate (NSAID) 290 mg

Pull To Open

This Package is for Households Without Young Children.

• Relieves backaches, muscular aches & Pains

Extra Strength Pasin Relief

Fast Acting Advanced Formula

Tamper Evident Unit Dose Packets

073R073R

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-073349314-0733-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f54fffd8-6a25-761f-e053-2a95a90a3a10ba0fb514-d707-1f8c-e053-2995a90a680a2023-02-22WarningsExact identifier
spl id: f54fffd8-6a25-761f-e053-2a95a90a3a10
spl set id: ba0fb514-d707-1f8c-e053-2995a90a680a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.