OTIS CLAPP MYGREX- acetaminophen, phenylephrine hydrochloride tablet MEDI FIRST SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet MEDI FIRST PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet

Medi First Plus Sinus Pain and Pressure by

Drug Labeling and Warnings

Medi First Plus Sinus Pain and Pressure by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Purpose

Pain reliever

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to

■ common cold

■ hay fever or other respiratory allergies

Temporarily

■promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

■ reduces fever

Temporarily relieves minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ common cold

■ toothache

■ menstrual cramps

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

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

■ liver disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ heart disease

■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin

Stop use and ask a doctor if

■ symptoms do not improve within 7 days or are accompanied by a fever

■ pain or fever persists or gets worse

■ redness or swelling is present

■ any new symptoms appear

Do not exceed recommended doses.

If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

In case of 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. 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
• ■ avoid excessive heat and humidity

Inactive ingredients

corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate*, stearic acid.

*may contain

Questions or comments? 1-800-634-7680

Medi-First Plus Sinus Pain and Pressure Label

100 Tablets
(50 x 2's)
Medi First ® Plus
Sinus Pain and Pressure
Acetaminophen 500mg

Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children

Tamper Evident

Unit Dose Packets

Medi-First Sinus Pain and Pressure Label

100Tablets
(50 x 2)
Medi-First ®
Sinus Pain and Pressure

Sinus Pain Relief

Pull to Open

Aches & Fever Acetaminophen 500 mg

Nasal Decongestant Phenylephrine HCl 5 mg

This Package is For Households Without Young Children

Tamper Evident
Unit Dose Packets

Otis Clapp Mygrex Label

Otis Clapp
Quality and Integrity Since 1840
MYGREX ™
Pain Reliever-Decongestant
Advanced Relief
For Sinus/Headaches
See Warnings and Directions on Side Panel
Acetaminophen 500 mg,
Phenylephrine HCl 5 mg
Tear Out Along Perforation To Dispense
PROFESSIONAL HEALTHCARE
300 Tablets (150 PACKETS OF 2)

INGREDIENTS AND APPEARANCE

OTIS CLAPP MYGREX 
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-148
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-148-03	150 in 1 BOX	12/30/2008
1	NDC: 47682-148-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-148-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

MEDI FIRST SINUS PAIN AND PRESSURE 
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-146
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-146-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-146-48	125 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-146-13	250 in 1 BOX	12/30/2008
3	NDC: 47682-146-99	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-146-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/30/2008

MEDI FIRST PLUS SINUS PAIN AND PRESSURE 
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-158
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)

Product Characteristics
Color	blue (blue)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-158-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-158-48	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 final	part341	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-146, 47682-148, 47682-158) , repack(47682-146, 47682-148, 47682-158)