Other
Drug Facts
Unishield Extra Strength Non Aspirin Tablet
FDA Label NDC 49314-1783
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product Unishield Extra Strength Non Aspirin (NDC 49314-1783). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500 mg.
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
■ if you are allergic to acetaminophen or any of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if you have
■ liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if
■ you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop using and ask a doctor if
■ pain gets worse or lasts more than for more than 10 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see overdose warning)
Adults and children 12 years and over
■ take 2 tablets every 6 hours while symptoms last.
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
Children under 12 years Ask a doctor
Other Safety Information
Other information
■ store at room temperature 59°-86°F (15°-30°C)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid, titanium dioxide*.
* may contain
Otc - Questions
Questions or comments? 800-480-5855
Unishield Extra Strength Non-Aspirin
Unishield
Extra Strength
Non-Aspirin
Pain Reliever/Fever Reducer
100 Tablets/2Tablets Per Packet
Acetaminophen 500 mg
Pull To Open
This Package is for Households Without Young Children.
• Relieves headaches, backaches, muscular aches and more
• Temporarily relieves fever
Compare active ingredients to:
Extra Strength Tylenol®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
Unishield Extra Strength Non-Aspirin Label
Unishield
Extra Strength
Non-Aspirin
Pain Reliever/Fever Reducer
100 Tablets/2Tablets Per Packet
Acetaminophen 500 mg
Pull To Open
This Package is for Households Without Young Children.
• Relieves headaches, backaches, muscular aches and more
• Temporarily relieves fever
Compare active ingredients to:
Extra Strength Tylenol®
Registered Trademark of McNeil Consumer Healthcare
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.
