Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Nighttime Sleep Aid
- Manufacturer
- Safeway, Inc. | P & L Development, LLC
- Effective date
- 2018-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:39:28
Label at a glance#
ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take only one dose per day (24 hours) - see Overdose warning swallow whole; do not crush, chew, or dissolve adults & children 12 yrs & over one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor
Storage and handling
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) and high humidity protect from light
Contacts and useful links#
Websitewww.safeway.com
www.safeway.com
www.safeway.comLabel contents#
Full prescribing information#
Active ingredient (in each softgel)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- heart disease
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers or any other sleep-aid.
When using this product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take only one dose per day (24 hours) - see Overdose warning
- swallow whole; do not crush, chew, or dissolve
- adults & children 12 yrs & over
- one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F) and high humidity
- protect from light
Inactive ingredients
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide
Questions or comments?
Call 1-888-SAFEWAY Monday-Friday 7AM-6PM PST
Principal Display Panel
Compare to ZzzQuil® active ingredient*
Nighttime Sleep-Aid
Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid
Non Habit-Forming
Not for Treating Cold or Flu
See Warnings
SOFTGELS (LIQUID FILLED CAPSULES)
DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99
PLEASANTON, CA 94566-0009
PRODUCT OF CANADA
*This product is not manufactured or distributed by The Procter & Gamble Company, VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company.
Failure to follow these warnings could result in serious consequences.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Sleep Aid
- Diphenhydramine Hydrochloride
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- FD&C RED NO. 40
- SORBITOL
- TITANIUM DIOXIDE
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21130-225 | 21130-225-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 13 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, COATED / ORAL | 12.96 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / ORAL | 10932 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / SUBCUTANEOUS | 16 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, COATED / ORAL | 42.12 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 66b6d65f-2cf0-4af9-846e-1a6ed10dfe2d | c10ddb43-2c44-49f3-bfdc-d47a628b2c08 | 2018-12-26 | Warnings | 66b6d65f-2cf0-4af9-846e-1a6ed10dfe2d c10ddb43-2c44-49f3-bfdc-d47a628b2c08 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.