FDA.report

NIGHTTIME SLEEP AID CAPLETS

Set ID
45ae6964-2a2b-4158-ba49-9ac642383460
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:10

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each caplet)

Diphenhydramine HCl 25mg

Purpose

nighttime sleep-aid

Uses

Uses

for the relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Warnings

Directions And Dosage

Directions

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

Other Label Information

Other information

each caplet contains: calcium 25 mg store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPLA DISPLAY PANEL

Nighttime sleep-aid Diphenhydramine HCI 25 mg - Nighttime Sleep-Aid Does NOT contain pain reliever Non-habit forming 36 Caplets

Products

NDC Codes

Ingredients

NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness

WARNINGS SECTION

WARNINGS SECTION

Warnings

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 25 mg store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPLA DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime sleep-aid Diphenhydramine HCI 25 mg - Nighttime Sleep-Aid Does NOT contain pain reliever Non-habit forming 36 Caplets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
26823

Legacy File Index

FolderFileDate
otc292996b3-4bb0-f497-e063-6294a90a674b.xml2024-12-15
otc0bf2f33a-af9b-30a8-e063-6294a90a9349.xml2023-12-08
otcee8efe74-df79-41b8-e053-2a95a90ac2bc.xml2022-11-30
otccfe56bf4-5d28-7d78-e053-2995a90a45af.xml2021-11-04
otcc1097e13-4ca6-320c-e053-2995a90a6983.xml2021-04-29
otcNT AID.jpg2021-04-29