OTC Medication Information: ALLERGY RELIEF

ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated
Meijer, Inc.

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.

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
• 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 used on skin

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

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

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. 1(800)222-1222

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 children 12 years of age and over	1 to 2 tablets
children 6 to under 12 years of age	1 tablet
children under 6 years of age	do not use this product in children under 6 years of age

Other information

• each tablet contains: calcium 25 mg
• store at controlled room temperature 20°-25°C (68°-77°F)
• protect from moisture and light
• see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red No 27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-287-1915

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL

Carton 24 ct.

Carton 48 ct

ALLERGY RELIEF diphenhydramine hydrochloride tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0036 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C RED NO. 27 ANHYDROUS DIBASIC CALCIUM PHOSPHATE LECITHIN, SOYBEAN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WATER

Product Characteristics Color pink Score no score Shape OVAL (capsule shaped) Size 12mm Flavor Imprint Code S4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79481-0036-2 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (79481-0036-2) 2 NDC:79481-0036-4 4 TABLET, FILM COATED in 1 BLISTER PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2023

Labeler — Meijer, Inc. (006959555)

Revised: 05/2023 Meijer, Inc.