Dollar General 44-018

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 the child has

OTC - ASK DOCTOR SECTION

• a breathing problem such as chronic bronchitis
• glaucoma

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

• marked drowsiness may occur
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

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

• do not take more than directed
• find right dose on chart below
• mL = milliliter
• only use the dose cup provided
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

Age (yr)	Dose (mL)
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	5 mL to 10 mL

Other information

STORAGE AND HANDLING SECTION

• each 5 mL contains: sodium 4 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™ health

Compare to active
ingredient of
Children’s Benadryl®
Dye-Free Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCl
12.5 mg per 5 mL
Oral Solution

Antihistamine

Relieves:
• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat

Dye free/Alcohol free

4 FL OZ (118 mL)

Bubble Gum
Flavor

Related RxNorm Concepts#

Product Linked Resources#

DailyMed Product Concepts#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Allergy Childrens
• Diphenhydramine HCl
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• ANHYDROUS CITRIC ACID
• GLYCERIN
• PROPYLENE GLYCOL
• WATER
• SODIUM BENZOATE
• SODIUM CHLORIDE
• TRISODIUM CITRATE DIHYDRATE
• SUCRALOSE
• XANTHAN GUM

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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.