EASY CARE FIRST AID DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, film coated

Easy Care First Aid Diphenhydramine by

Drug Labeling and Warnings

Easy Care First Aid Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by Tender 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

Easy Care First Aid Diphenhydramine

1 Caplet

Made in USA

See card for complete product information

INGREDIENTS AND APPEARANCE

EASY CARE FIRST AID DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44224-0017
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: 44224-0017-2	50 in 1 BOX	01/01/2012
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 44224-0017-1	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 - Tender Corporation (064437304)