SLEEPINAL- diphenhydramine hydrochloride capsule 
Blairex Laboratories, 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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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 50 mg

Purpose

night-time 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
  • trouble urinating due to the enlargement of the 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 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 right away.

Directions

Adults and children 12 years and over:

  • take 1 capsule at bedtime if needed, or as directed by a doctor.

Other information

Inactive ingredients

FD&C blue no. 1, FD&C red no. 3, gelatin, lactose, magnesium stearate, talc

Manufactured for:

Blairex Laboratories, Inc.
P.O. Box 2127 Columbus, IN 47202 USA

Telephone
Questions or Comments? Call TOLL FREE 1-800-252-4739
www.sleepinal.net

MAXIMUM STRENGTH

Sleepinal ®

Night-time Sleep-Aid CAPSULES

NDC 50486-616-32

Non-habit Forming

One Capsule Dosage

Wake Up Refreshed

32 Capsules

Diphenhydramine Hydrochloride

PACKAGE NOT CHILD RESISTANT

Principal Display Panel

MAXIMUM STRENGTH

Sleepinal ®

Night-time Sleep-Aid CAPSULES

NDC 50486-616-16

Non-habit Forming

One Capsule Dosage

Wake Up Refreshed

16 Capsules

Diphenhydramine Hydrochloride

Principal Display Panel
SLEEPINAL 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50486-616
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Product Characteristics
Colorblue (transparent) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code SLEEPINAL;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50486-616-324 in 1 CARTON10/01/1999
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50486-616-162 in 1 CARTON10/01/1999
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33810/01/1999
Labeler - Blairex Laboratories, Inc. (092575133)

Revised: 11/2021
Document Id: d17a5ee8-52bc-3d1d-e053-2995a90aa804
Set id: 111e891d-acd8-44f9-b958-09cb876d388c
Version: 4
Effective Time: 20211123
 
Blairex Laboratories, Inc.