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#
Contacts and useful links#
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
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
Products#
Every source-derived product name is available through these pages.
- Unishield Back Pain Off
- Acetaminophen, Caffeine, Magnesium Salicylate
- MALTODEXTRIN
- MAGNESIUM SALICYLATE
- SALICYLIC ACID
- CAFFEINE
- HYPROMELLOSES
- CELLULOSE, MICROCRYSTALLINE
- STARCH, CORN
- POVIDONE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49314-0733 | 49314-0733-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MAGNESIUM SALICYLATE | 41728CY7UX | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f54fffd8-6a25-761f-e053-2a95a90a3a10 | ba0fb514-d707-1f8c-e053-2995a90a680a | 2023-02-22 | Warnings | f54fffd8-6a25-761f-e053-2a95a90a3a10 ba0fb514-d707-1f8c-e053-2995a90a680a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
