FDA.reportPublic FDA data

Compoz

Manufacturer
Medtech Products Inc.
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:23:34

Label at a glance#

ProductCompoz MAXIMUM STRENGTH nighttime sleep aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by your doctor. store at controlled room temperature 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (per soft gel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Use

INDICATIONS & USAGE SECTION

helps reduce difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age.
  • with other products containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by your doctor.

Other information

SPL UNCLASSIFIED SECTION

store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, purified water, sorbitol-sorbitan *may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-800-443-4908

©2016 Distributed by Medtech Products, Inc.
Tarrytown, NY 10591
A Prestige Brands Company

Compoz® MAXIMUM STRENGTH nighttime sleep aid Diphenhydramine HCl

One Capsule Dose

24 Easy-to-Swallow
Soft Gel Liquid Capsules

TAMPER EVIDENT: THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compoz
Diphenhydramine HCI
24 easy to swallow gel capsules

PRINCIPAL DISPLAY PANEL Compoz Diphenhydramine HCI 24 easy to swallow gel capsulesPRINCIPAL DISPLAY PANEL Compoz Diphenhydramine HCI 24 easy to swallow gel capsules

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-213-242020-06-30C16284748780-19d75b9cf-d11e-f424-e053-dadaa90a57ceCompoz
63029-213-242020-01-31C16284748780-19d75b9cf-d11e-f424-e053-dadaa90a57ceCompoz

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-21363029-213-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
a8930b23-27cc-434f-a572-f64ae3605a8f2e32caf9-888d-4826-8d84-7aca2f5b03b62020-07-02WarningsExact identifier
spl id: a8930b23-27cc-434f-a572-f64ae3605a8f
spl set id: 2e32caf9-888d-4826-8d84-7aca2f5b03b6

Reported adverse events (FAERS/openFDA)#

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