FDA.reportPublic FDA data

Awaken

Manufacturer
Hyland's Inc.
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:46:04

Label at a glance#

ProductAwaken
Active ingredientTHUJA OCCIDENTALIS LEAFY TWIG, SULFUR, PHOSPHORIC ACID, DIBASIC POTASSIUM PHOSPHATE, DELPHINIUM STAPHISAGRIA SEED, SEPIA OFFICINALIS JUICE, SODIUM CHLORIDE, DAPHNE MEZEREUM BARK
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of difficulty waking, fatigue, anxiousness, drowsiness, irritability and worry.

Dosage and administration

Adults & Children 12 years and over: dissolve 1-2 tablets under tongue 3 times per day.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Natural relief of fatigue, drowsiness and irritability

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Purpose

Kali Phosphoricum 6X HPUS

difficulty waking, fatigue, anxiousness

Mezereum 12X HPUS

drowsiness

Natrum Muriaticum 6X HPUS

irritability, fatigue, drowsiness

Phosphoricum Acidum 6X HPUS

irritability, worry

Sepia 30X HPUS

drowsiness

Staphysagria 30X HPUS

irritability, drowsiness

Sulphur 12X HPUS

irritability, drowsiness

Thuja Occidentalis 30X HPUS

drowsiness, irritability

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of difficulty waking, fatigue, anxiousness, drowsiness, irritability and worry.

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask doctor before use if pregnant or breast-feeding. Do not use  • more than directed  • if you have a known allergy to any ingredient in this product.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper band is broken or missing.

In case of emergency

SPL UNCLASSIFIED SECTION

contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults & Children 12 years and over: dissolve 1-2 tablets under tongue 3 times per day.

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 50 TABLETS BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-habit forming

NDC 54973-3333-1

HOMEOPATHIC

SINCE 1903

Hyland's®

Awaken

Natural relief of fatigue,

drowsiness and irritability*

50 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 194 MG

CartonCarton

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-333354973-3333-1, 54973-3333-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
SULFUR70FD1KFU70ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB

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
32d9a321-02bf-898b-e063-6394a90a66605e8295ee-5d87-09e4-e053-2991aa0a619e2025-04-15WarningsExact identifier
spl set id: 5e8295ee-5d87-09e4-e053-2991aa0a619e

Reported adverse events (FAERS/openFDA)#

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