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SLEEP AID MAXIMUM STRENGTH (diphenhydramine hcl) capsule
[Mckesson (Sunmark)]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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 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

INGREDIENTS & APPEARANCE

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-074
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-074-032 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:49348-074-061 in 1 CARTON
232 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 9/2012
 
Mckesson (Sunmark)