FDA.reportPublic FDA data

Childrens Allergy Relief

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2022-07-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:56:40

Label at a glance#

ProductChildrens Allergy Relief Dye-Free
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

find right dose on chart below mL = milliliter; FL OZ = fluid ounce use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. 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

Storage and handling

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

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

  • glaucoma
  • a breathing problem such as chronic bronchitis

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • find right dose on chart below
  • mL = milliliter; FL OZ = fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

1-844-428-2538

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24/7 life
BY 7-ELEVEN™

Dye-Free

CHILDREN'S
Allergy Relief

Diphenhydramine HCl 12.5 mg
Antihistamine

Relieves:
Sneezing, Runny Nose,
Itchy Throat or Nose,
Itchy, Watery Eyes

Alcohol Free / Sugar Free

compare to Children's Benadryl® Allergy active ingredient*

Dosing cup included

Cherry
Flavor

QUALITY GUARANTEED

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children's Benadryl® Allergy.

50844  ORG121701736

DISTRIBUTED BY 7-ELEVEN, INC.
IRVING, TX 75063   WWW.7-ELEVEN.COM

Satisfaction Guaranteed 1-800-255-0711

7-Eleven 44-017
7-Eleven 44-017

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-25350844-253-36

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
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
532c0d17-fdd5-41e0-9a96-16e218a04cdf0ada1809-2efa-4489-974c-6b67f2328bd32023-07-26WarningsExact identifier
spl set id: 0ada1809-2efa-4489-974c-6b67f2328bd3

Reported adverse events (FAERS/openFDA)#

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