SLEEP AID NIGHTTIME- diphenhydramine hcl tablet, film coated 
Walgreen Company

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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Walgreens 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

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • use caution when driving a motor vehicle or operating machinery

  • drowsiness will occur

  • avoid alcoholic beverages

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

Other information

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?

1-800-426-9391

Principal Display Panel

NDC 0363-0367-12

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED

NIGHTTIME
Sleep Aid
Diphenhydramine HCl 25 mg
Nighttime Sleep Aid

• For a restful night's sleep
• Does not contain pain reliever
• Safe, non-habit forming

100
MINI-CAPLETS

Compare to Simply Sleep® active ingredient‡‡

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING†Walgreens Pharmacist Recommended.

Walgreens Pharmacist Survey Study,
November 2014.
‡‡This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
50844    REV0516B36712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
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Walgreens 44-367

Walgreens 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0367
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;367
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0367-08 2 in 1 CARTON 06/10/2000
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:0363-0367-13 1 in 1 CARTON 06/10/2000
2 250 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0363-0367-12 1 in 1 CARTON 06/10/2000
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0363-0367-91 1 in 1 CARTON 06/10/2000
4 125 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 06/10/2000
Labeler - Walgreen Company (008965063)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(0363-0367)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(0363-0367)

Revised: 11/2016
Document Id: 0bf12147-1672-4d39-af83-3e934e5b4ab3
Set id: ec3618dd-8713-4f3c-b639-fc240021c7be
Version: 7
Effective Time: 20161115
 
Walgreen Company