MEDIQUE AT HOME DIPHEN- diphenhydramine hcl tablet, film coated

Medique at Home Diphen by

Drug Labeling and Warnings

Medique at Home 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

Active ingredient (in each caplet)

Diphenhydramine Hydrochloride 25 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

■ temporarily relieves these symptoms due to hay fever or other respiratory allergies

■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes

■ temporarily relieves these symptoms due to the common cold

■ runny nose ■ sneezing

WARNINGS

Warnings

DO NOT USE

Do not use

■ to make a child sleepy

■ with any other product containing diphenhydramine, even one that is used on skin.

ASK DOCTOR

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

WHEN USING

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

■ take every 4 to 6 hours, or as directed by a doctor

■ do not take more than 6 times in 24 hours

Adults and children12 years and over 1 to 2 caplets

Children 6 to under 12 years 1 caplet

Children under 6 years do not use

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 68º-77ºF (20º-25ºC)

■ protect from light

■ TAMPER EVIDENT child resistant packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

QUESTIONS

Questions or comments? 1-800-634-7680

PRINCIPAL DISPLAY PANEL

Medique® @ Home

Diphen Caplets

Diphenhydramine HCl 25 mg

Antihistamine

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(1 Caplet Per Packet)

Compare to the active ingredient in Benadryl® Ultratab® Tablets

INGREDIENTS AND APPEARANCE

MEDIQUE AT HOME DIPHEN 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-166
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-166-50	50 in 1 BOX	02/01/2021
1		1 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	M012	02/01/2021

Labeler - Unifirst First Aid Corporation (832947092)