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

Medi First Plus Non-Aspirin Extra Strength by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

• headache
• toothache
• minor arthritis pain
• muscular aches
• common cold
• menstrual cramps

For the reduction of fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets 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

• 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 more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

• liver disease

Ask a doctor or pharmacist before use if

• you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

• symptoms do not improve
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children. In case of accidental 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.

Directions

• do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain

QUESTIONS

Questions or comments? 1-800-634-7680

Medi-First XS Non-Aspirin 500 mg Label

100 Tablets

(50 x 2)

Medi-First®

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

Aches, Fever ● Acetaminophen 500mg

Pull to Open

Compare active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

This Package is For Households Without Young Children

Tamper Evident Unit Dose Packets

Medi-First Plus XS Non-Aspirin Label

100Tablets

(50 x 2's)

Medi First® Plus

Extra Strength

Non-Aspirin

Acetaminophen/Acetaminofeno 500mg

Pull To Open

This Package is For Households Without Young Children

Pain Reliever/Fever Reducer

Compare Active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

Medique XS APAP 500 mg Label

Medique®

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pull to Open

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDIQUE APAP EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-175
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
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-175-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008
2	NDC: 47682-175-13	250 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-175-33	50 in 1 BOX	12/30/2008
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-175-48	125 in 1 BOX	12/30/2008
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 47682-175-64	12 in 1 BOX	12/30/2008
5		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 not final	part343	12/30/2008

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-804
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-804-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-804-48	125 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-804-13	250 in 1 BOX	12/30/2008
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-804-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008
5	NDC: 47682-804-50	25 in 1 BOX	12/30/2008
5		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 not final	part343	12/30/2008

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-904
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-904-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-904-48	125 in 1 BOX	12/30/2008
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 not final	part343	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-175, 47682-804, 47682-904) , repack(47682-175, 47682-804, 47682-904)