GOOD REMEDIES Nighttime Sleep Aid Caplets

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:32:27

Label at a glance#

ProductGOOD REMEDIES Nighttime Sleep Aid Caplets
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use

Storage and handling

• each caplet contains: calcium 22 mg • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Use

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use
• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

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

When using this product
• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of serious underlying medical illness.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

• each caplet contains: calcium 22 mg
• store at room temperature between 20°-25°C (68°-77°F)
• protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of TYLENOL PM® Simply Sleep®*

Helps you fall asleep
Safe, non-habit forming

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®.

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

Distributed by: Strive Pharmaceuticals Inc.,
East Brunswick, NJ 08816
PRODUCT OF INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD REMEDIES SLEEP AID 70692-011-06GOOD REMEDIES SLEEP AID 70692-011-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

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

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
70692-011-06GOOD REMEDIES Nighttime Sleep Aid Caplets60 in 1 BOTTLETABLET602
70692-011-06GOOD REMEDIES Nighttime Sleep Aid Caplets1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-011GOOD REMEDIES NIGHTTIME SLEEP AID CAPLETS (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [STRIVE PHARMACEUTICALS INC.]2Current NDC, 2 package rows20241102_24fba735-cedf-9d15-e063-6394a90af873.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-01170692-011-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
ndc (package): 70692-011-06
ndc (product): 70692-011
ndc11 (package): 70692001106
spl id: ded4acec-e3d4-42cd-a4ce-a6d2baff1c80
spl set id: 24fba735-cedf-9d15-e063-6394a90af873

Reported adverse events (FAERS/openFDA)#

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