MEDI-FIRST PLUS EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated MEDI-FIRST EXTRA STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated MEDIQUE EXTRA STRENGTH APAP- acetaminophen tablet, film coated

Medique Extra Strength Apap by

Drug Labeling and Warnings

Medique Extra Strength Apap by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Prestige Packaging, Medique Products. 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.

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 (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*

* May contain

PRINCIPAL DISPLAY PANEL

Medique

Extra Strength APAP

Non-Aspirin Tablets

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

Pain Reliever / Fever Reducer Acetaminophen 500 mg

Compare active ingredient to Tylenol®

Registered McNeil Products

Tamper Evident Unit Dose Packets

24 Tablets

(12 x 2)

INGREDIENTS AND APPEARANCE

MEDI-FIRST PLUS EXTRA STRENGTH NON-ASPIRIN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-274
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white ((White to Off-White))	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	G552
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-274-33	50 in 1 BOX	03/28/2024
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-274-48	125 in 1 BOX	03/28/2024
2		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	03/28/2024

MEDI-FIRST EXTRA STRENGTH NON-ASPIRIN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-273
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)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white ((White to Off-White))	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	G552
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-273-13	250 in 1 BOX	03/28/2024
1	NDC: 47682-273-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-273-33	50 in 1 BOX	03/28/2024
2	NDC: 47682-273-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-273-48	125 in 1 BOX	03/28/2024
3	NDC: 47682-273-99	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-273-50	25 in 1 BOX	03/28/2024
4	NDC: 47682-273-99	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	03/28/2024

MEDIQUE EXTRA STRENGTH APAP 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-272
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
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white ((White to Off-White))	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	G552
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-272-13	250 in 1 BOX	03/28/2024
1	NDC: 47682-272-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-272-33	50 in 1 BOX	03/28/2024
2	NDC: 47682-272-99	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-272-48	125 in 1 BOX	03/28/2024
3	NDC: 47682-272-99	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-272-64	12 in 1 BOX	03/28/2024
4	NDC: 47682-272-99	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	03/28/2024

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(47682-272, 47682-273, 47682-274)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	pack(47682-272, 47682-273, 47682-274)