FDA.reportPublic FDA data

up and up nighttime sleep-aid

Manufacturer
Target Corporation
Effective date
2015-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:10

Label at a glance#

Productup and up nighttime sleep-aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

• take only one dose per day (24 hours) – see Overdose warning • use dose cup or tablespoon adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Storage and handling

• each 30 mL dose (2 tablespoons) contains: sodium 23 mg • store at room temperature • protect from light. Does not meet USP .

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup or 2 tablespoons)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours) – see Overdose warning
  • use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11673-730-92

Compare to active ingredient in ZzzQuil™*


nighttime

sleep-aid

diphenhydramine HCl

  • non-habit forming
  • alcohol free

BERRY FLAVOR


SEE WARNINGS NOT FOR TREATING COLD OR FLU

12 FL OZ (354 mL)

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil®

Questions? Call 1-800-910-6874

094 01 0778 R00 ID274446

Distributed by Target Corporation Minneapolis, MN 55403

©2014 Target Brands, Inc.

Shop Target.com

up and up nighttime sleep aid Berry Flavor
up and up nighttime sleep aid Berry Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-730-922020-01-31C16284748780-19d75b9d0-e2a5-f424-e053-dadaa90a57ceup and up nighttime sleep-aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-730-92up and up nighttime sleep-aid354 mL in 1 BOTTLE, PLASTICLIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-730UP AND UP NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [TARGET CORPORATION]1Legacy NDC, 1 package rows20160225_0d1771df-d51c-4da6-b8ca-f8aacce5b9df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-73011673-730-92

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d1771df-d51c-4da6-b8ca-f8aacce5b9df0d1771df-d51c-4da6-b8ca-f8aacce5b9df2015-01-16WarningsExact identifier
spl id: 0d1771df-d51c-4da6-b8ca-f8aacce5b9df
spl set id: 0d1771df-d51c-4da6-b8ca-f8aacce5b9df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.