Quiet Calm: Homeopathic Product Information

QUIET CALM- avena sativa flowering top, ammonium bromide, matricaria chamomilla, arabica coffee bean, gelsemium sempervirens root, tryptophan, phosphoric acid and valerian liquid
Holistic Haven

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

ACTIVE INGREDIENTS:

Avena Sativa 1X, Ammonium Bromatum 3X, Chamomilla 6X, Coffea Cruda 6X, Gelsemium Sempervirens 6X, L-Tryptophan 6X, Phosphoricum Acidum 6X, Valeriana Officinalis 30X.

INDICATIONS:

For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

WARNINGS:

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

Keep out of reach of children. In case of overdose, get medical help or contact physician or Poison Control Center right away.

Do not use if seal is broken or missing.

Store in a cool dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact physician or Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day or as directed by a health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For the temporary relief of symptoms related to sleep dysfunction, mood swings, and nervous anxiety.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist. By: Holistic Haven

Westlake Village, CA 91362

holistichavenpharmacy.com

1-866-676-HEAL

PACKAGE LABEL DISPLAY:

Holistic Haven

Quiet

Calm

HOMEOPATHIC

2 FL OZ (59 ml)

Quiet Calm
(click image for full-size original)

QUIET CALM
avena sativa, ammonium bromatum, chamomilla, coffea cruda, gelsemium sempervirens, l-tryptophan, phosphoricum acidum, valeriana officinalis liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70476-0004
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 1 mL
AMMONIUM BROMIDE (BROMIDE ION) AMMONIUM BROMIDE 3 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 6 [hp_X] in 1 mL
PHOSPHORIC ACID (PHOSPHORIC ACID) PHOSPHORIC ACID 6 [hp_X] in 1 mL
VALERIAN (VALERIAN) VALERIAN 30 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70476-0004-1 59 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/10/2019
Labeler — Holistic Haven (005153286)
Registrant — Apotheca Company (844330915)
Establishment
Name Address ID/FEI Operations
Apotheca Company 844330915 manufacture (70476-0004), api manufacture (70476-0004), label (70476-0004), pack (70476-0004)

Revised: 01/2021 Holistic Haven

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