AWAKEN- daphne mezereum bark,sulfur,delphinium staphisagria seed,sepia officinalis juice,sodium chloride,phosphoric acid,dibasic potassium phosphate and thuja occidentalis leafy twig tablet

Awaken by

Drug Labeling and Warnings

Awaken by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Natural relief of fatigue, drowsiness and irritability

Drug Facts

• 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

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

WARNINGS

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.

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

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

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

In case of emergency

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

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

INACTIVE INGREDIENT

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 50 TABLETS BOTTLE CARTON

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

INGREDIENTS AND APPEARANCE

AWAKEN 
daphne mezereum bark,sulfur,delphinium staphisagria seed,sepia officinalis juice,sodium chloride,phosphoric acid,dibasic potassium phosphate and thuja occidentalis leafy twig tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_X]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	12 [hp_X]
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152)	DIBASIC POTASSIUM PHOSPHATE	6 [hp_X]
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white (Off-White to White)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3333-1	1 in 1 CARTON	12/01/2017
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3333-2	4 in 1 POUCH; Type 0: Not a Combination Product	12/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2017

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3333) , pack(54973-3333) , label(54973-3333)