OTC Medication Information: Compoz MAXIMUM STRENGTH Nighttime Sleep Aid

COMPOZ MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hydrochloride 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.

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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code P50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-213-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (63029-213-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 01/15/2016 10/31/2020
Labeler — Medtech Products Inc. (122715688)

Revised: 07/2020 Medtech Products Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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