MEDIQUE DIPHEN- diphenhydramine hydrochloride tablet, film coated

Medique Diphen by

Drug Labeling and Warnings

Medique Diphen 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 caplet)

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

• runny nose
• sneezing
• itching nose or throat
• itchy-watery eyes

Temporarily relieves these symptoms due to the common cold

• runny nose
• sneezing

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one that is used on skin.

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcohol 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

If pregnant or breast feeding,

ask a health professional before use.

Keep out of the reach of children.

In case of overdose, contact a physician or poison control center immediately.

Directions

• do not use more than directed

Adults and children: (12 years and older)

Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

• each caplet may contain: calcium 25mg
• protect from light
• use by expiration date on packet
• store at room temperature 59º-86ºF (15º-30ºC
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, titanium dioxide

* may contain

Questions or comments?

1-800- 634-7680

184R Medique Diphen Label

Medique®

Diphen

Hay Fever / Allergies

Antihistamine Diphenhydramine HCl 25 mg

This Package is for Households without Young Children

Antihistomine Diphenhydramine HCl 25mg

22 Caplets

(24 x 1)

Compare active ingredient to Benadryl®

Registered Trademark Parke davis

Tamper Evident Unit Dose Packets

Medique 167 Diphen Principal Display Panel

Medique®

Diphen

Hay Fever / Allergies

Antihistamine Diphenhydramine HCl 25 mg

This Package is for Households without Young Children

Antihistomine Diphenhydramine HCl 25mg

22 Caplets

(24 x 1)

Compare active ingredient to Benadryl®

Registered Trademark Parke davis

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDIQUE DIPHEN 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-184
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	061;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-184-32	12 in 1 BOX	01/01/2012	11/01/2012
1	NDC: 47682-184-46	1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-184-64	24 in 1 BOX	01/01/2012
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-184-47	200 in 1 BOX	01/01/2012
3		1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-184-46	1 in 1 PACKET; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2012

MEDIQUE DIPHEN 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-167
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	048;D
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-167-32	12 in 1 BOX	01/01/2012	11/01/2012
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-167-64	24 in 1 BOX	01/01/2012
2		1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-167-47	200 in 1 BOX	01/01/2012
3	NDC: 47682-167-46	1 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 47682-167-46	1 in 1 PACKET; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2012

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-167, 47682-184) , repack(47682-167, 47682-184)