Label: UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet
UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated
- NDC Code(s): 49314-1753-3, 49314-1763-3, 49314-1773-3
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 31, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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.
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- QUESTIONS
-
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
-
INGREDIENTS AND APPEARANCE
UNISHIELD EXTRA STRENGTH NON-ASPIRIN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1773 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 44;148 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-1773-3 50 in 1 BOX 06/01/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/01/2023 UNISHIELD EXTRA STRENGTH NON-ASPIRIN
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1753 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-1753-3 50 in 1 BOX 03/01/2021 11/01/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/01/2021 11/01/2023 UNISHIELD EXTRA STRENGTH NON-ASPIRIN
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1763 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-1763-3 50 in 1 BOX 03/01/2021 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/01/2021 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations LNK International, Inc, 832867837 manufacture(49314-1773)