REAL RELIEF- arnica montana, bryonia, causticum, cinchona officinalis, dulcamara, hydrastis canadensis, kali bromatum, sulphur tablet

Real Relief by

Drug Labeling and Warnings

Real Relief by is a Homeopathic medication manufactured, distributed, or labeled by Homeolab International (Canada) inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients HPUS:

Arnica montana (Leopard's bane)            8[hp-X]

Bryonia (White bryony)                          8 [hp-X]

Causticum (Hahnmann's causticum)        8 [hp-X]

Cinchona officinalis (Peruvian bark)        8 [hp-X]

Dulcamara (Bittersweet)                          8 [hp-X]

Hydrastis canadensis (Golden seal)          8 [hp-X]

Kali bromatum (Potassium bromide)       8 [hp-X]

Sulphur (Sublimed sulfur)                       8 [hp-X]

PURPOSE

Purpose

Homeopathic remedy helps relieve symptoms of tinnitus:

• Rigging and buzzing in the ears
• Ear pain & pressure
• Headache

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INDICATIONS & USAGE

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated

• with tinnitus
• Rigging and buzzing in the ears
• Ear pain & pressure
• Headache

WARNINGS

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

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 poison control center immediately.

DOSAGE & ADMINISTRATION

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

STORAGE AND HANDLING

Other information

• Store at room temperature.
• Do not use if seal is broken or missing.

INACTIVE INGREDIENT

Inactive ingredients

Lactose, Magnesium Stearate.

Product label

INGREDIENTS AND APPEARANCE

REAL RELIEF 
arnica montana, bryonia, causticum, cinchona officinalis, dulcamara, hydrastis canadensis, kali bromatum, sulphur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71971-6032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	8 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	8 [hp_X]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	8 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	8 [hp_X]
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	8 [hp_X]
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	8 [hp_X]
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06)	POTASSIUM BROMIDE	8 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	HLB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71971-6032-0	1 in 1 CARTON	01/01/2020
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71971-6032-5	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
3	NDC: 71971-6032-8	1 in 1 CARTON	01/01/2020
3		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2020

Labeler - Homeolab International (Canada) inc (203639455)