FDA.reportPublic FDA data

ZzzQuil ULTRA, Lil Drug Store

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:18:39

Label at a glance#

ProductZzzQuil ULTRA, Travel BASIX
Active ingredientDOXYLAMINE SUCCINATE
Label structure11 sections

Dosage and administration

Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

Use

  • helps to reduce difficulty in falling asleep

Warnings

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

Do not use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

  • a sedative or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When using this product

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • take only at bedtime

Stop use and ask a doctor if

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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?1-877-881-5813

Distributor information

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
vicks.com Patents: www.pg.com/patents


Vicks ® is a trademark of The Procter & Gamble Company
used with permission. All other products and brands are
the property of their respective owners.


Product packaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc.,9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 M-F (8 AM-4:30 PM CST)

ZzzQuil TM ULTRA, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil TM

ULTRA

NIGHTTIME SLEEP-AID

Doxylamine succinate tablets, 25 mg nighttime sleep-aid

From the makers of NyQuil ®

Clinically tested, proven effective

[tablet image]

actual size

1 TABLET

PER DOSE

3

TABLETS

[Lil' Drug Store logo]

PDP/PackagePDP/Package

ZzzQuil TM UKTRA, Travel BASIX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil TM

ULTRA

NIGHTTIME SLEEP-AID

Doxylamine succinate tablets, 25 mg nighttime sleep-aid

From the makers of NyQuil ®

Clinically tested, proven effective

[tablet image]

actual size

1 TABLET

PER DOSE

3

TABLETS

[Travel BASIX logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN3
2548540Zzzquil Ultra 25 MG Oral TabletPSN3
2548540doxylamine succinate 25 MG Oral Tablet [Zzzquil Ultra]SBD3
1101446doxylamine succinate 25 MG Oral TabletSCD3
2548540Zzzquil Ultra 25 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6451-3ZzzQuil ULTRA, Travel BASIX3 in 1 CARTONTABLET33
66715-6451-3ZzzQuil ULTRA, Travel BASIX1 in 1 POUCHTABLET13
66715-9751-2ZzzQuil ULTRA, Lil Drug Store1 in 1 POUCHTABLET13
66715-9751-2ZzzQuil ULTRA, Lil Drug Store2 in 1 CARTONTABLET23
66715-9751-3ZzzQuil ULTRA, Lil Drug Store1 in 1 POUCHTABLET13
66715-9751-3ZzzQuil ULTRA, Lil Drug Store3 in 1 CARTONTABLET33

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-645166715-6451-3
66715-975166715-9751-3, 66715-9751-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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
ZzzQuil ULTRA, Travel BASIXDOXYLAMINE SUCCINATELil' Drug Store Products, Inc.0f8c7219-7b40-27c6-e063-6294a90a27d92025-12-01WarningsExact identifier
ndc (package): 66715-9751-2
ndc (package): 66715-6451-3
ndc (package): 66715-9751-3
ndc (product): 66715-9751
ndc (product): 66715-6451
ndc11 (package): 66715975103
ndc11 (package): 66715975102
ndc11 (package): 66715645103
spl id: 44e705b6-fd79-dd85-e063-6294a90a7d6f
spl set id: 0f8c7219-7b40-27c6-e063-6294a90a27d9

Reported adverse events (FAERS/openFDA)#

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