REAL RELIEF- drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquid

Real Relief by

Drug Labeling and Warnings

Real Relief by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoire Atlas Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients HPUS:

Drosera 1C (Sundew)

Arnica montana 3C (Leopards Bane)

Bryonia 3C (White Bryony)

Cetraria islandica 1C (Iceland Moss)

Coccus cacti 3C (Cochineal)

Corallium rubrum 3C (Red Coral)

Stannum metallicum 3C (Tin)

Camomilla 4C (German Chamomille)

Coffea crudea 4C (coffee)

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharcopoeia of the United States

PURPOSE

Purpose

Drosera 1C (Sundew)................................................dry cough

Arnica montana 3C (Leopard's Bane)...........................aches and pains, chest congestion

Bryonia 3C (White Bryony) .......................................painful cough

Cetraria islandica 1C (Iceland Moss)...........................cough with expectoration

Coccus cacti 3C (Cochineal)......................................cough with expectoration

Corallium rubrum 3C (Red Coral)..............................painful cough

Stannum metallicum 3C (Tin)...................................cough, chills, and lessens mucus

Camomilla 4C (German Chamomille).........................restlessness, irritability, nocturnal awakenings

Coffea crudea 4C (coffee)........................................restlessness and sleeplessness

INDICATIONS & USAGE

Uses This homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve

symptoms associated with nighttime cough and cold*:

dry cough cough with expectoration

chest congestion fever aches and pains

WARNINGS

Warnings

Stop use and ask a doctor if Pain & cough gets worse

or lasts more than 5 days

Fever gets worse or lasts more than 3 days Redness

or swelling is present New symptoms occur Cough

comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition

If you are pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental

overdose, contact a medical professional or a poison

control center immediately.

DOSAGE & ADMINISTRATION

Directions Do not exceed recommended dosage Do not take with

food Take before bedtime. Repeat every 8 hours as needed and reduce

with improvement or as directed by a health care professional.

Age.....................................................................Dose

Adults and Children 12 + years...............................10 ml or 2 teaspoons (tsp)

Children 6 to 11 years of age..................................5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age....................................2.5 ml or 1/2 teaspoon (tsp)

STORAGE AND HANDLING

Other information do not use if seal is broken or missing

Store at room temperature.

INACTIVE INGREDIENT

Inactive ingredients Purified water, sorbitol,

caramel, sodium benzoate, potassium sorbate, citric acid

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REAL RELIEF 
drosera, arnica montana, bryonia, cetraria islandica, coccus cacti, corallium rubrum, stannum metallicum, camomilla, coffea crudea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63388-920
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	1 [hp_C]  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]  in 100 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	3 [hp_C]  in 100 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C]  in 100 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C]  in 100 mL
CORALLIUM RUBRUM WHOLE (UNII: 22Z32PWR7R) (CORALLIUM RUBRUM WHOLE - UNII:22Z32PWR7R)	CORALLIUM RUBRUM WHOLE	3 [hp_C]  in 100 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C]  in 100 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	4 [hp_C]  in 100 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [hp_C]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARAMEL (UNII: T9D99G2B1R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63388-920-45	1 in 1 CARTON	03/03/2018
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63388-920-49	1 in 1 CARTON	03/03/2018
2		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 63388-920-44	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/03/2018

Labeler - Laboratoire Atlas Inc (247880834)

Registrant - Laboratoire Atlas Inc (247880834)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Atlas Inc		247880834	manufacture(63388-920)