Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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WAL SOM NIGHTTIME SLEEP AID- diphenhydramine hcl capsule 
Walgreens

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 softgel)

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness.

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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 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

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

  • store at 15-30°C (59-86°F)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink


Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Unisom® SleepGels® active ingredient††

NIGHTTIME SLEEP AID

Wal-Som

DIPHENHYDRAMINE HCL 50 mg/NIGHTTIME SLEEP AID

NIGHTTIME

MAXIMUM STRENGTH SOFTGELS

  • Fall asleep fast

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

ONE LIQUID-FILLED SOFTGEL PER DOSE

**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Product Label

Diphenhydramine HCL 50 mg

Wal-Som Nighttime Sleep Aid

WAL SOM NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-0816
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-0816-321 in 1 BOX10/30/2019
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 0363-0816-601 in 1 BOX10/30/2019
260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33810/30/2019
Labeler - Walgreens (008965063)

Revised: 11/2019
 
Walgreens


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