OTIS CLAPP VALIHIST- acetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated MEDIQUE MEDICIDIN D- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

Medique Medicidin D by

Drug Labeling and Warnings

Medique Medicidin D 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

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

Temporarily relieves minor aches and pains associated with

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

Temporarily relieves nasal congestion due to

• common cold
• hay fever or other respiratory allergies

Temporarily

• reduces fever
• relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
• promotes nasal and/or sinus drainage; relieves sinus congestion and pressure

WARNINGS

Warnings

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

• more than 12 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
• with any other drug using the above active ingredients
• 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
• glaucoma
• chronic bronchitis or emphysema
• difficulty in urination due to enlargement of the prostate gland

When using this product

• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

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 dosage. 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 hours. Do not take more than 12 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

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, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-634-7680

Principal Display Panel - Otis Clapp Valihist Label

Otis Clapp

Quality and Integrity Since 1840

VALIHIST ™

Decongestant-Antihistamine

Pain Reliever-Fever Reducer

Antihistamine- Decongestant

For Allergies, Colds, Runny Nose

See Warnings and Directions on Side Panel

Acetaminophen 325 mg,

Chlorpheniramine Maleate 2mg

Phenylephrine HCl 5 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 TABLETS (150 PACKETS OF 2)

Principal Display Panel - Medique Medicidin D Label

Medique®

Medicidin-D

Cold and Allergy Relief

This Package is for Households without Young Children

Pull to Open

Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

Antihistamine ● Chlorpheniramine Maleate 2mg

Nasal Decongestant ● Phenylephrine HCl 5mg

100Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

OTIS CLAPP VALIHIST 
acetaminophen,chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-543
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	AZ;275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-543-03	150 in 1 BOX	12/30/2008
1	NDC: 47682-543-99	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-543-99	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

MEDIQUE MEDICIDIN D 
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	AZ;275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-120-64	12 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-120-33	50 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-120-47	100 in 1 BOX	12/30/2008
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-120-13	250 in 1 BOX	12/30/2008
4	NDC: 47682-120-99	2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 47682-120-99	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

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-120, 47682-543) , repack(47682-120, 47682-543)