FDA.reportPublic FDA data

Adult Allergy Relief

Manufacturer
Wal-Mart Stores, Inc. | Aurohealth LLC
Effective date
2020-11-27
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:47

Label at a glance#

ProductAdult Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours not to exceed 300 mg in 24 hours mL = milliliter   Age (yr) Dose (mL) Adult and children 12 years and older 10 mL to 20 mL Children under 12 years Consult a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Storage and handling

each 20 mL contains: sodium 56 mg store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient [in each 20 mL]

Diphenhydramine HCl, USP 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet
  • trouble urinating due to enlarged prostate

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

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • not to exceed 300 mg in 24 hours
  • mL = milliliter
 Age (yr)
Dose (mL)
Adult and children 12 years and older
10 mL to 20 mL
Children under 12 years
Consult a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains: sodium 56 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or Comments?
1-888-287-1915
DISTRIBUTED BY: Wal Mart Stores, Inc.,
Bentonville, AR 72716
PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-986-24

equate™

Quality
Guaranteed

Maximum Strength/Dye Free
Adult
Allergy
Relief
Liquid Medication

Diphenhydramine Hydrochloride
50 mg/20 mL Oral Solution
Antihistamine

Relief of:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat

Alcohol Free
Cherry Flavor

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)




Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-98649035-986-24

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CHERRYBUC5I9595WIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
472ec094-d4c8-4fd5-aecd-a189f0326aa65cdc51ed-9895-4fb7-9201-3a1040c0a1bf2020-11-27WarningsExact identifier
spl id: 472ec094-d4c8-4fd5-aecd-a189f0326aa6
spl set id: 5cdc51ed-9895-4fb7-9201-3a1040c0a1bf

Reported adverse events (FAERS/openFDA)#

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