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- NDC Code(s): 0363-0672-12, 0363-0672-19, 0363-0672-21, 0363-0672-51
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 29, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
- Purpose
Nighttime sleep-aid
- Uses
- for relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
- 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 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
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.
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
- do not take more than directed
- adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
- Other information
- each caplet contains: calcium 65 mg
- avoid excessive heat (greater than 100°F) or humidity
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
- Questions or comments?
1-800-426-9391
- Principal display panel
Walgreens
Compare to VICKS®
ZzzQuil® active ingredient††NDC 0363-0672-51
Wal-Sleep Z®
DIPHENHYDRAMINE HCl 25 mg /
NIGHTTIME SLEEP AIDNIGHTTIME CAPLETS
NOT FOR TREATING
PAIN, COLD OR FLU365 CAPLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSINGWalgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® ZzzQuil®.50844 REV0419A67251 REV0619
DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT RD.
DEERFIELD, IL 60015
100% SATISFACTION
GUARANTEED
walgreens.com
©2018 Walgreen Co.
Walgreens 44-672
- INGREDIENTS AND APPEARANCE
WAL-SLEEP Z
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0672 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color purple Score no score Shape OVAL Size 14mm Flavor Imprint Code 44;672 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0672-51 365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/24/2015 2 NDC:0363-0672-21 1 in 1 CARTON 07/24/2015 10/14/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-0672-19 1 in 1 CARTON 07/24/2015 07/15/2019 3 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0363-0672-12 1 in 1 PACKAGE 07/24/2015 11/27/2020 4 100 in 1 BOTTLE, PLASTIC; 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 07/24/2015 10/14/2024 Labeler -Walgreen Company(008965063)
Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0363-0672) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(0363-0672) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(0363-0672) , pack(0363-0672) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-0672)
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Find additional resources
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Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
WAL-SLEEP Z- diphenhydramine hcl tablet, film coated
Number of versions: 13
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Nov 30, 2022 | 13 (current) | download |
| Nov 9, 2021 | 12 | download |
| Nov 10, 2020 | 11 | download |
| Nov 29, 2019 | 10 | download |
| Nov 14, 2018 | 9 | download |
| Aug 20, 2018 | 8 | download |
| Aug 16, 2017 | 7 | download |
| Apr 28, 2017 | 6 | download |
| Feb 3, 2017 | 5 | download |
| Dec 1, 2016 | 4 | download |
| Aug 4, 2016 | 3 | download |
| Jul 20, 2016 | 2 | download |
| Jul 24, 2015 | 1 | download |
RxNorm
WAL-SLEEP Z- diphenhydramine hcl tablet, film coated
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN |
| 2 | 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD |
| 3 | 1658757 | Wal-Sleep Z 25 MG Oral Tablet | PSN |
| 4 | 1658757 | diphenhydramine hydrochloride 25 MG Oral Tablet [Wal-Sleep Z] | SBD |
| 5 | 1658757 | Wal-Sleep Z 25 MG Oral Tablet | SY |
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NDC Codes
WAL-SLEEP Z- diphenhydramine hcl tablet, film coated
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 0363-0672-12 |
| 2 | 0363-0672-19 |
| 3 | 0363-0672-21 |
| 4 | 0363-0672-51 |
