FDA.reportPublic FDA data

MAX Sleep Junior Childrens SLEEP AID

Manufacturer
Akron Pharma
Effective date
2024-06-23
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:51:05

Label at a glance#

ProductMAX Sleep Junior Childrens SLEEP AID
Active ingredientMELATONIN
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

factsfacts

HEALTH CLAIM SECTION

  • Drug-Free
  • Easy to use dropper
  • Safe, gentle and effective

* This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.

SAFE HANDLING WARNING SECTION

Store at room temperature 

WARNINGS SECTION

Caution: This product may cause drowsiness. Do not exceed recommended serving. Do not take or combine with other products containing melatonin or products that cause sedation or drowsiness. Consult a doctor if you or your child is experiencing long-term sleep difficulties.
Do not use if you or your child is allergic to any of the ingredients.

PRECAUTIONS SECTION

Do not drive or operate machinery while taking melatonin

DOSAGE & ADMINISTRATION SECTION

SUGGESTIONS FOR USE: Using the enclosed dropper, administer 30-60 minutes before bedtime.
Take only as directed. For occasional use only. May be administered directly into the mouth or into a liquid that will be consumed immediately. After administration, a slight warming sensation in the mouth is normal. Talk with your doctor's care for a medicine or are under a doctor's care for medical condition. Do not use if safety seal is broken. Clean dropper and reclose cap tightly after each use.

Manutactured lor:
Akron Pharma, Inc.
Fairtield, NJ 07004
www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253039melatonin 1 MG in 1 mL Oral SolutionPSN1
253039melatonin 1 MG/ML Oral SolutionSCD1
253039melatonin 1 MG per 1 ML Oral SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0128-1MAX Sleep Junior Childrens SLEEP AID30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301
71399-0128-1MAX Sleep Junior Childrens SLEEP AID1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0128MAX SLEEP JUNIOR CHILDRENS SLEEP AID (MELATONIN) SOLUTION/ DROPS [AKRON PHARMA]12 package rows20240624_d075ed24-90bf-4ebc-8bae-86a858da60dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0128-1ML - Milliliter71399-012811b01f4b-d43d-41b3-bcc6-0eacf8c17dc212025-05-14

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-012871399-0128-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELATONINJL5DK93RCLACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melatonin 1527MELATONINProfessional Complementary Health Formulaseb411c99-fe69-400d-b452-95d8d6d754b82026-01-08WarningsName fallback
generic name: MELATONIN
MELATONIN CORDMELATONINEnergique, Inc.9a59554b-14c4-4c79-9db1-0a38b3c152f22024-10-28WarningsName fallback
generic name: MELATONIN
Melatonin PhenolicMELATONINEnergique, Inc.895cb8a5-33ea-4764-86a6-1da513dcd2c12024-10-28WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.8951e5e9-5d8f-4808-b247-208760fae6562024-10-17WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINDeseret Biologicals, Inc.4ea9b3dc-a6f7-48b0-b0a7-ac2951bc575d2024-04-01WarningsName fallback
generic name: MELATONIN
MelatoninMELATONINBioActive Nutritional, Inc.cd82eb5d-a44a-4512-ad65-0fffae70d1d02017-07-25WarningsName fallback
generic name: MELATONIN

Reported adverse events (FAERS/openFDA)#

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