UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet UNISHIELD EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated

Unishield Extra Strength Non-Aspirin by

Drug Labeling and Warnings

Unishield Extra Strength Non-Aspirin by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 500 mg.

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.

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

ASK DOCTOR

Ask a doctor before use if you have

■ liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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 59º-86ºF (15º-30ºC)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose*, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid*, titanium dioxide*.

* may contain

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

INGREDIENTS AND APPEARANCE

UNISHIELD EXTRA STRENGTH NON-ASPIRIN 
acetaminophen tablet

Product 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 coated

Product 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 coated

Product 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)