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Sleep-Aid Maximum Strength by Freds Inc

Medically reviewed on February 27, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Freds Inc
NDC Code: 55315-230

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
  • 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 a 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)

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

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Sleep-Aid

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl, 50 mg

Softgels

Compare to the active ingredient in Maximum Strength Unisom® SleepGels®*

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

Product Label

Fred's Sleep-Aid Maximum Strength

SLEEP-AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-230
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 
SORBITAN 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint CodeP50;A99
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-230-321 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
132 CAPSULE (32 CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

 
Freds Inc

← See all Sleep-Aid Maximum Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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