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Nighttime Sleep Aid by SuperValu (Equaline)

Medically reviewed on Dec 18, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: SuperValu (Equaline)
NDC Code: 41163-401

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 caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

provides relief of occasional sleeplessness

Warnings

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

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • drowsiness will occur
  • avoid alcoholic beverages
  • 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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not take more than directed

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

Other information
  • each caplet contains: calcium 25 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake,
magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-932-7948

Principal Display Panel

Compare to TYLENOL® SIMPLY SLEEP® active ingredient**

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

NIGHTTIME SLEEP-AID

Diphenhydramine HCl, 25 mg

  • helps to fall asleep fast
  • for a restful night's sleep
  • safe, non-habit forming

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Tamper evident: Do not use if imprinted safety seal under cap is broken or missing

Product Label

Diphenhydramine HCl 25 mg

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeT129;S25
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-401-242 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
112 TABLET (12 TABLET) in 1 BLISTER PACK
2NDC:41163-401-011 BOTTLE (1 BOTTLE) in 1 BOX
2100 TABLET (100 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33610/31/2012
Labeler - SuperValu (Equaline) (006961411)
Registrant - P and L Development of New York Corporation (800014821)

 
SuperValu (Equaline)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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