COMPOZ MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled 
Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Compoz

Drug Facts

Active ingredient (per soft gel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

  • 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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic beverages.

Stop use and ask a doctor if

  • sleeplessness persists 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.

Keep out of reach of children.

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

Directions

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

Other information

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

Inactive ingredients

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

Questions?

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

Compoz
Diphenhydramine HCI
24 easy to swallow gel capsules

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

COMPOZ  MAXIMUM STRENGTH NIGHTTIME SLEEP AID
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-213-241 in 1 CARTON01/15/201610/31/2020
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/15/201610/31/2020
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2020
Document Id: a8930b23-27cc-434f-a572-f64ae3605a8f
Set id: 2e32caf9-888d-4826-8d84-7aca2f5b03b6
Version: 2
Effective Time: 20200702
 
Medtech Products Inc.