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.
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
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
■ 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
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 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.