SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl 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.

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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

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 an enlargement of the prostate gland

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

sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a 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 a doctor

Other information

Store at controlled room temperature 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

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

Quality guaranteed or your money back

Product Label

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

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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-231-32	1 in 1 CARTON	07/01/2010	01/01/2022
1		32 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41520-231-40	1 in 1 BOX	07/01/2010	01/01/2022
2		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/01/2010	01/01/2022

Labeler - Care One (American Sales Company) (809183973)

Registrant - P & L Development, LLC (800014821)

Revised: 8/2017

Document Id: 1af82f2f-b874-404a-99f7-ee0641653b02

Set id: 851e7e5f-14bd-480a-a775-9ac1ac854ff1

Version: 3

Effective Time: 20170810

Care One (American Sales Company)