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)Aspirin (NSAID)* 162 mg Caffeine 32.4 mg Salicylamide (NSAID)* 152 mg *nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducerPain reliever/fever reducerAdjuvantPain reliever/fever reducer
Indications & Usage
emporarily relieved minor aches and pains associated with■ headaches ■ muscular aches ■ minor arthritis pain ■ back pain ■ colds ■ toothache ■ menstrual crampsTemporarily reduces fever.
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: Aspirin and Salicylamide 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 nonsteroidal anti-inflammatory drugs (NSAIDs), 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■ 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 pain for more than 10 days unless directed by a doctor■for more than 3 days for fever unless directed by a doctor■ with any other pain reliever/fever reducerl)
Otc - Ask Doctor
Ask a doctor before use if■ stomach bleeding warning applies to you■ you have a history of stomach problems (such as heartburn, upset stomach or stomach pain)■ you have heart disease, liver cirrhosis, or kidney disease■ you have asthma or high blood pressure■ you are taking a diuretic
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for■ anticoagulation■ diabetes■ gout■ arthritis
Ask a doctor or pharmacist before use if you have■ liver disease
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■ symptoms do not improve■ pain or fever gets worse■ ringing in the ears or loss of hearing occurs■ new symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
It is especially important not to use aspirin and salicylamide 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.Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage.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 directedAdults and children(12 years and older): take 2 tablets every 4 hours as needed with a full glass of water. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
Children under 12 years of age: Ask a doctor
Other Safety Information
Other information■ 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 ingredientsFD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid.
Otc - Questions
Questions or Comments? 800-480-5855
Unishield Pain Zapper Label
UnishieldPain ZapperExtra Strength Pain Relief100 Tablets/ 2 Tablets Per PacketAcetaminophen 110 mg. Aspirin (NSAID) 162 mgCaffeine 32.4 mg. Salicylamide (NSAID) 152 mgPull To OpenThis Package is for Households wirhout Young Children.• Fast effective relief from tough headaches• Non-drowsy formula contains caffeineFast Acting Advanced FormulaTamper Evident Unit Dose Packets
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