LIL DRUG STORE NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet 
Lil' Drug Store Products, Inc.

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.

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Lil' Drug Store® Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • relief of occasional sleeplessness
  • helps reduce difficulty in falling asleep

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 tranquilizers or sedatives

When using this product

  • avoid alcoholic drinks

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 and overtake 2 caplets at bedtime if needed or as directed by your doctor
children under 12 yearsdo not use

Other information

  • each caplet may contain: calcium 25mg
  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59°-86°F (15°-30°C)
  • protect from light
  • see bottom panel for expiration date and lot number

Inactive ingredients

carnauba wax1, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate1, hypromellose, lactose1, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 801, titanium dioxide

1
may contain

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)

PRINCIPAL DISPLAY PANEL - 20 Caplet Pouch Carton - 9743

EZ Paks™
Stores & Travels Easily!

Compare to the active ingredients in
Simply Sleep®*

NIGHTTIME

Sleep-Aid
Nighttime Sleep Aid
Diphenhydramine HCl, 25 mg

  • For a restful night's sleep
  • Safe, non-habit forming

20 CAPLETS
IN 10 POUCHES OF 2 CAPLETS

Lil'
Drug Store®

Principal Display Panel - 20 Caplet Pouch Carton - 9743

PRINCIPAL DISPLAY PANEL - 20 Caplet Pouch Carton - 9843

EZ Paks™
Stores & Travels Easily!

Compare to the active ingredients in
Simply Sleep®*

NIGHTTIME

Sleep-Aid
Nighttime Sleep Aid
Diphenhydramine HCl, 25 mg

  • For a restful night's sleep
  • Safe, non-habit forming

20 CAPLETS
IN 10 POUCHES OF 2 CAPLETS

Lil'
Drug Store®

Principal Display Panel - 20 Caplet Pouch Carton - 9843
LIL DRUG STORE NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9743
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax (UNII: R12CBM0EIZ)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
D&C red NO. 27 (UNII: 2LRS185U6K)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
lactose, unspecified form (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code T;061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9743-810 in 1 CARTON06/02/201102/03/2016
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/02/201102/03/2016
LIL DRUG STORE NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9843
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
Carnauba Wax (UNII: R12CBM0EIZ)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
D&C red NO. 27 (UNII: 2LRS185U6K)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
lactose, unspecified form (UNII: J2B2A4N98G)  
Magnesium Stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code 048;D
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9843-810 in 1 CARTON06/02/201102/03/2016
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/02/201102/03/2016
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 1/2017
Document Id: 8a808d6d-64d8-49ef-b580-80f2e75017b9
Set id: 9d482806-ef59-41cd-97ce-698aab3c2551
Version: 2
Effective Time: 20170126
 
Lil' Drug Store Products, Inc.