COMPOZ MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

Compoz by

Drug Labeling and Warnings

Compoz by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

COMPOZ  MAXIMUM STRENGTH NIGHTTIME SLEEP AID
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-213
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-213-24	1 in 1 CARTON
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/15/2016

Labeler - Medtech Products Inc. (122715688)