SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule 
Care One (American Sales Company)

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 (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use

Warnings

Do not give to children under 12 years of age.

Do not use this product

Ask a doctor before use if you have

Ask doctor or pharmacist before use if you are now taking

sedatives or tranquilizers

When using this product

avoid alcoholic beverages

Stop use and ask a doctor if

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

Other information

Inactive ingredients

edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Principal Display Panel

Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®*

Maximum Strength

Sleep- Aid

Helps to reduce difficulty falling asleep

Diphenhydramine HCl 50 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

www.care1.com

© 2009 S&S BRANDS, INC.

Quality guaranteed or your money back

Product Label

CareOne

Diphenhydramine HCl 50 mg

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-231
Route of Administration ORAL DEA Schedule     
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)  
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;A99
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-231-32 1 in 1 CARTON
1 32 in 1 BOTTLE
2 NDC:41520-231-40 1 in 1 BOX
2 40 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/01/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: a4f98a63-62b8-4b27-a9d6-5bbfbb80d611
Set id: 851e7e5f-14bd-480a-a775-9ac1ac854ff1
Version: 1
Effective Time: 20121227
 
Care One (American Sales Company)