Your browser does not support JavaScript! SLEEP AID MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]
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SLEEP AID MAXIMUM STRENGTH (diphenhydramine hcl) capsule
[Care One (American Sales Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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

© 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-231
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:41520-231-321 in 1 CARTON
132 in 1 BOTTLE
2NDC:41520-231-401 in 1 BOX
240 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
 
Care One (American Sales Company)

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