Easy Care First Aid Diphenhydramine: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 27 HYPROMELLOSES LACTOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE TITANIUM DIOXIDE

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:44224-0017-2 50 PACKET in 1 BOX contains a PACKET 1 1 TABLET, FILM COATED in 1 PACKET This package is contained within the BOX (44224-0017-2) 2 NDC:44224-0017-1 1 TABLET, FILM COATED in 1 PACKET None

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)

Revised: 10/2019 Tender Corporation