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Sleep Aid Nighttime by Family Dollar Services Inc

Medically reviewed on January 3, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Family Dollar Services Inc
NDC Code: 55319-367

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.

Family Wellness 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously 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 (1-800-222-1222) right away.

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information
  • each caplet contains: calcium 28 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

FAMILY
wellness

COMPARE TO THE ACTIVE
INGREDIENT OF SIMPLY SLEEP®*

Nighttime
Sleep Aid
Diphenhydramine HCl / Nighttime Sleep-Aid

Safe, Non-Habit Forming
Does Not Contain Pain Reliever

24 CAPLETS 25 mg each

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Simply Sleep®.           50844        REV0814C36708

Not 100% satisfied?
Return package and unused product within 30 days to any
Family Dollar store for a refund (with receipt) or exchange.

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD, MATTHEWS, NC 28105 USA

Family Wellness 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-367
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-367-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:55319-367-121 BOTTLE in 1 CARTON
2100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/200010/25/2019
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55319-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55319-367)

 
Family Dollar Services Inc

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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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