RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:46

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

Uses

for relief of occasional sleeplessness reduces time to fall alseep if you have difficulty falling asleep

Warnings

Warnings

Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have glaucoma heart disease a breathing problem such as emphysema, asthma, or chronic bronchitis difficulty in urination due to an enlargement of prostate gland Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness. be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use.

Directions And Dosage

Directions

adults and children 12 years and over take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor children under 12 years do not use

Other Label Information

Other information

store at room temperature between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) protect from light, heat and moisture

Inactive ingredients

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

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

Packaging

Label Images#

70692834-1
70692834-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY2

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-834-71RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel275 in 1 BOTTLECAPSULE, LIQUID FILLED2752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-834RIGHT REMEDIES MAXIMUM STRENGTH NIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]2Current NDC, 1 package rows20250327_2d64f5c2-dfa9-e5f5-e063-6294a90a0711.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-83470692-834-71

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness reduces time to fall alseep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have glaucoma heart disease a breathing problem such as emphysema, asthma, or chronic bronchitis difficulty in urination due to an enlargement of prostate gland Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid When using this product avoid alcoholic beverages and other drugs that cause drowsiness. be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor children under 12 years do not use

Other information

STORAGE AND HANDLING SECTION

store at room temperature between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Unisom ® SleepGels ® * fall asleep fast safe, non-habit forming TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Chatem, Inc., owner of the registered trademark Unisom ® . Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 PRODUCT OF INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML