Indications and uses
for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
sleep aid
- Manufacturer
- Target Corporation | LNK International, Inc.
- Effective date
- 2021-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:28:46
Label at a glance#
Productsleep aid nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed take only one dose per day (24 hours) adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years: do not use
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive heat above 40ºC (104ºF) and high humidity see end flap for expiration date and lot number protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each liquid-filled capsule)
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- 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.
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
- do not take more than directed
- take only one dose per day (24 hours)
- adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid excessive heat above 40ºC (104ºF) and high humidity
- see end flap for expiration date and lot number
- protect from light
Inactive ingredients
edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol
Questions or comments?
Call 1-800-910-6874
Principal Display Panel
Compare to active ingredient in Vicks® ZzzQuil®*
NDC 11673-654-22
nighttime sleep aid
diphenhydramine HCl, 25 mg
nighttime sleep aid
non-habit forming
up&up®
48 SOFTGELS
SEE WARNINGS
NOT FOR TREATING PAIN, COLD OR FLU
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark VICKS® ZzzQuil®.
50844 REV0319B65422
Product of China
Packaged and Quality Assured in the USA
Distributed by Target Corporation
Minneapolis, MN 55403
©2019 Target Brands, Inc.
Shop Target.com
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- sleep aid nighttime
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11673-654 | 11673-654-08, 11673-654-22 |
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 |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 14 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| GELATIN | GELATIN | 2G86QN327L | WAFER / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / RESPIRATORY (INHALATION) | 100 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 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 |
|---|---|---|---|---|---|---|
| 1cd5c39a-d008-4842-9808-a323cdc7756f | bbabb2db-b7da-4e9f-9dc3-bd7d96eb3a66 | 2021-11-09 | Warnings | 1cd5c39a-d008-4842-9808-a323cdc7756f bbabb2db-b7da-4e9f-9dc3-bd7d96eb3a66 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.