InstaRelief Nighttime Sleep Aid

Manufacturer
DXM Pharmacuetical, Inc.
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:38:12

Label at a glance#

ProductInstaRelief Nighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For relief of occasional sleeplessness. Helps to reduce difficulty falling asleep. Reduces time to fall asleep. Warnings

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 3mL) (one dose) Diphenhydramine HCI, 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional sleeplessness.
  • Helps to reduce difficulty falling asleep.
  • Reduces time to fall asleep. Warnings

Warning

WARNINGS SECTION

Do not use

  • for children under 12 years of age, or
  • with any other product containing diphenhydramine, even one used on skin.

Do not take this product, unless directed by a doctor

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

Do not take this product ifyou are taking sedatives or tranquilizers, without first consulting your doctor. Avoid alcoholic beverages while taking this product. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.


If pregnant or breast-feeding, ask a doctor before use.


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

DOSAGE & ADMINISTRATION SECTION

​Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 1 dose (3 mL) (50 mg) in any24-hour period
  • measure only 3 mL with dosing syringe provided
  • keep dosing syringe with product
  • mL = milliliter - fl oz = fluid ounce
agedose
adults and children 12 years and over

3mL at bedtime

children under 12 yearsdo not use

Other information 

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if seal on the bottle is broken.
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, stevia, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-289-7626 between 10 a.m. to 4 p.m. CST, Monday through Friday or visit our website www.InstaRelief.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description
image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2671699diphenhydrAMINE HCl 50 MG in 3 mL Oral SolutionPSN3
2671699diphenhydramine hydrochloride 16.7 MG/ML Oral SolutionSCD3
2671699diphenhydramine HCl 50 MG per 3 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371598120198GTIN-13: 0371598120198
EAN-13: 0371598120198
GTIN-12: 371598120198
UPC-A: 371598120198
GTIN storage (14 digits): 00371598120198
IMAGE-1-120.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71598-120-19InstaRelief Nighttime Sleep Aid1 in 1 CARTONLIQUID13
71598-120-19InstaRelief Nighttime Sleep Aid120 mL in 1 BOTTLELIQUID1203

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
71598-12071598-120-19

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#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-07full-release2026-06-01 00:23:08

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
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsExact identifier
ndc (package): 71598-120-19
ndc (product): 71598-120
ndc11 (package): 71598012019
spl id: 4081a49d-9a39-2867-e063-6294a90ac822
spl set id: e0459e71-32dd-4715-b103-bb14db42c5f3

Reported adverse events (FAERS/openFDA)#

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