SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule 
Mckesson (Sunmark)

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

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 maximum strength unisom sleepgels® active ingredient*

Sleep aid

Maximum strength

Diphenhydramine Hydrochloride

Easy to swallow

Another quality product distributed by McKesson

one post street,

San Francisco, CA 94104

Money back gurantee

Please visit us at www.sunmarkbrand.com

Questions or comments? Call toll free: 1-877-753-3935 

Product Label

Sunmark sleep aid

Diphenhydramine HCl 50 mg

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-074
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:49348-074-03 2 in 1 CARTON
1 8 in 1 BLISTER PACK
2 NDC:49348-074-06 1 in 1 CARTON
2 32 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
Document Id: 96227853-31b8-42d1-bb9f-959be3e118d0
Set id: 6dff2020-84f5-4a34-a683-7a22c5416814
Version: 1
Effective Time: 20120924
 
Mckesson (Sunmark)