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NDC 65808-0322-01 Real Relief 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Real Relief 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Real Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GMP Laboratories of America, Inc.. The primary component is ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; MATRICARIA CHAMOMILLA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP.

Product Information

NDC	65808-0322
Product ID	65808-322_b7a03493-0510-2bd7-e053-2a95a90a16e8
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Real Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chamomila, Coffea Cruda, Eriodictyon californicum, Histaminum, Ipecacuanha, Lobelia inflata, Sambucus nigra, Solidago virgaurea
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	8; 8; 8; 8; 8; 8; 8; 8
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ARABICA COFFEE BEAN; ERIODICTYON CALIFORNICUM LEAF; HISTAMINE DIHYDROCHLORIDE; IPECAC; LOBELIA INFLATA; MATRICARIA CHAMOMILLA; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP
Labeler Name	GMP Laboratories of America, Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 65808-0322-01 (65808032201)

Pricing Information	N/A
NDC Package Code	65808-322-01
Billing NDC	65808032201
Package	1 BOTTLE in 1 CARTON (65808-322-01) / 90 TABLET in 1 BOTTLE
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7a030d9-0644-4778-e053-2995a90a57c7 Details

SPL UNCLASSIFIED SECTION

Active Ingredients HPUS:

Chamomila 8 [hp_X]

Coffea Cruda 8 [hp_X]

Eriodictyon californicum (Yerba santa) 8 [hp_X]

Histaminum 8 [hp_X]

Ipecacuanha (Ipecac) 8 [hp_X]

Lobelia inflata (Indian tobacco) 8 [hp_X]

Sambucus nigra (European elder) 8 [hp_X]

Solidago virgaurea (Goldenrod) 8 [hp_X]

SPL UNCLASSIFIED SECTION

Purpose

Homeopathic remedy helps relieve symptoms of asthma:

gasping for air
dry cough
difficulty breathing
irritability and nocturnal awakenings
wheezing
cough with mucus, cough with expectoration
restlessness and sleeplessness
excess mucus
irregular respiration

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.

SPL UNCLASSIFIED SECTION

Uses

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

gasping for air
difficulty breathing
wheezing
coughing
excess mucus

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

SPL UNCLASSIFIED SECTION

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 4 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

SPL UNCLASSIFIED SECTION

Other information

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

SPL UNCLASSIFIED SECTION

Inactive ingredients

Lactose, Magnesium Stearate.

Product label

INGREDIENTS AND APPEARANCE

REAL RELIEF

chamomila, coffea cruda, eriodictyon californicum, histaminum, ipecacuanha, lobelia inflata, sambucus nigra, solidago virgaurea tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65808-322
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	8 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	8 [hp_X]
ERIODICTYON CALIFORNICUM LEAF (UNII: 2Y7TIQ135H) (ERIODICTYON CALIFORNICUM LEAF - UNII:2Y7TIQ135H)	ERIODICTYON CALIFORNICUM LEAF	8 [hp_X]
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	8 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	8 [hp_X]
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	8 [hp_X]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	8 [hp_X]
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	8 [hp_X]

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65808-322-01	1 in 1 CARTON	01/01/2020
1		90 in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - GMP Laboratories of America, Inc. (876754375)

Revised: 12/2020

Document Id: b7a03493-0510-2bd7-e053-2a95a90a16e8

Set id: b7a030d9-0644-4778-e053-2995a90a57c7

Version: 2

Effective Time: 20201229

Search by Drug Name or NDC

NDC 65808-0322-01 Real Relief 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Real Relief 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 65808-0322-01 (65808032201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b7a030d9-0644-4778-e053-2995a90a57c7 Details

SPL UNCLASSIFIED SECTION

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Product label

INGREDIENTS AND APPEARANCE

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