Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use(s)

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Age (yr)	Dose (chewable tablets)
children under 2 years	do not use
children 2 to 5 years	do not use unless directed by a doctor
children 6 to 11 years	1 to 2 chewable tablets (12.5 mg to 25 mg)
adults and children 12 years and over	2 to 4 chewable tablets (25 mg to 50 mg)

Other information

SPL UNCLASSIFIED SECTION

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050
Monday through Friday 9AM – 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• Allergy Relief
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• D&C RED NO. 27 ALUMINUM LAKE
• D&C RED NO. 30 ALUMINUM LAKE
• ETHYLCELLULOSE, UNSPECIFIED
• DEXTRATES
• FD&C BLUE NO. 1 ALUMINUM LAKE
• HYDROXYPROPYL CELLULOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MANNITOL
• STEARIC ACID
• SUCRALOSE
• SUCROSE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.