Insomnia Relief by Homeocare Laboratories INSOMNIA RELIEF pellet

Insomnia Relief by

Drug Labeling and Warnings

Insomnia Relief by is a Homeopathic medication manufactured, distributed, or labeled by Homeocare Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avena sativa 3X, Coffea cruda 14x, Chamomilla 8X, Passiflora incarnata 8X, Stramonium 8X, Nux vomica 8X.

Purpose:

For the temporary relief of insomnia due to stress, worry, grief or excess caffeine; restlessness and night terrors in children.

Keep out of reach of children.

Keep out of reach of children.

Indications & Usage:

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times/day & at bedtime or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Warnings:

If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Keep out of reach of children. Do not use if cap seal is broken or missing.

Dosage & Administration:

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times/day & at bedtime or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Inactive ingredients:

Insomnia Relief

INGREDIENTS AND APPEARANCE

INSOMNIA RELIEF 
insomnia relief pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61727-307
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X]  in 4 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	14 [hp_X]  in 4 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	8 [hp_X]  in 4 g
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	8 [hp_X]  in 4 g
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	8 [hp_X]  in 4 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	8 [hp_X]  in 4 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61727-307-21	4 g in 1 TUBE; Type 0: Not a Combination Product	07/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/20/2012

Labeler - Homeocare Laboratories (088248828)

Registrant - Homeocare Laboratories (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
Homeocare Laboratories		088248828	manufacture(61727-307)