Nighttime Sleep Aid description, usages, side effects, indications, overdosage, supplying and lots more!

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Nighttime Sleep Aid

SuperValu (Equaline)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Nighttime Sleep Aid 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

Nighttime Sleep Aid
Diphenhydramine HCl 25 mg

Nighttime Sleep Aid

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41163-401
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
BLUE 11 mm T129;S25 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 100 in 1 BOTTLE
3 NDC:41163-401-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2012-10-31


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Be sure to consult your doctor before taking any medication!
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