Real Relief Natural Wellness Calming Syrup Liquid
FDA Label NDC 71971-9042

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeolab International (canada) Inc for the product Real Relief Natural Wellness Calming Syrup (NDC 71971-9042). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

ASAFOETIDA (ASAFETIDA) 8 [hp-X]

IGNATIA AMARA (IGNATUS BEAN)                        8 [hp-X]

VALERIANA OFFICINALIS (VALERIAN)                8 [hp-X]

AVENA SATIVA (OAT)                                                 8 [hp-X]

ARGENTUM NITRICUM (SILVER NITRATE)          8 [hp-X]

HYOSCYAMUS NIGER (HENBANE)                        8 [hp-X]

PAEONIA OFFICINALIS (PEONY)                             8 [hp-X]

STRAMONIUM (THORN APPLE)                               8 [hp-X]

ANCOCCULUS INDICUS (INDIAN BERRY)             8 [hp-X]

The letters 'HPUS' indicate that the compo nents in this pro duct are o fficially mo no g raphed in the Ho mo eo pathic Pharmaco po eia o f the United States.

Purpose

ASAFOETIDA                                  Restlessness and Anxiety

IGNATIA AMARA                            Nervousness

VALERIANA OFFICINALIS                Agitation

AVENA SATIVA                              Sleeplessness

ARGENTUM NITRICUM                   Nervousness

ARGENTUM NITRICUM                   Nervousness

HYOSCYAMUS NIGER                    Anguish and fear

PAEONIA OFFICINALIS                 Apprehension, anxiety and irritability

STRAMONIUM                             Nightmares and nervousness

COCCULUS INDICUS                    Lack of concentration

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of*: restlessness, nervousness, irritability, agitation, sleeplessness, lessen nightmares.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Warnings

Stop use and ask a doctor if symptoms worsen:

If you are pregnant or breast feeding, ask a health professional before.

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

Otc - Keep Out Of Reach Of Children

Directions

• Do not exceed recommended dosage

• Repeat every 6 hours and reduce with improvement or as directed by a health professional.
Age………………………………………………………….................Dose
Adults and Children 12 + years. ............................................10 ml or 2 teaspoon (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 ½ teaspoon (tsp)

Other Information

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

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Inactive Ingredients

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

Product Label

Image Description (Image 1)

Image Description (Image 1)

Image Description (Image 2)

Image Description (Image 2)

* Please review the disclaimer below.