SCHEDULING STATUS:

S0

PROPRIETARY NAME (AND DOSAGE FORM):

Night-Time MX Capsules

COMPOSITION:

Each dose (2 capsules) provides: %NRV

PM Fat Metabolising & Adrenal Support 200 mg *

Withania somnifera

(Ashwagandha root extract 15:1) 200 mg *

PM Recovery & Sleep Support 547 mg *

Passiflora incarnata

(Passion flower powder extract) 200 mg *

L-Tryptophan 147 mg *

Valeriana officinalis

(Valerian root powder extract) 133 mg *

L-Theanine 67 mg *

% Nutrient Reference Values (NRVs) for individuals 4 years and older

*%NRV not established

PHARMACOLOGICAL CLASSIFICATION:

Category D Complementary Medicines. 32.3 – Slimming preparation

PHARMACOLOGICAL ACTION:

Ashwagandha contains withanolides which are believed to have “anti-stress” effects by possibly suppressing stress-induced increases of dopamine receptors in the brain.

Passionflower contains a number of alkaloids believed to have sedative properties.

Valerian contains valepotriate constituents which have sedative effects.

L-Tryptophan is an amino acid which is able to cross the blood-brain barrier where it has sedative effects.

Theanine is an amino acid with relaxing and anti-anxiety effects.

INDICATION:

Night-Time MX is indicated when a deficiency of the active ingredients exists.

CONTRA-INDICATIONS:

If you suffer from a chronic medical condition, use this product under the supervision of your healthcare practitioner.

INTERACTION:

If you are taking chronic prescription medication, consult your health care practitioner before using this product. If you are using chronic medication for depression or anxiety consult your healthcare practitioner before using this product. Discontinue use of this product 2 weeks prior to any planned surgical procedure.

PREGNANCY AND LACTATION:

Pregnant and breastfeeding women should avoid using this product.

DOSAGE AND DIRECTIONS FOR USE:

Take 2 capsules 30 minutes before bed. Alternatively use as directed by your health and fitness adviser. Do not exceed the recommended dosage.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Discontinue the use of this product where there is sensitivity towards any of the ingredients.

KNOWN SYMPTOMS OF OVERDOSE AND TREATMENT:

Use only as directed.

IDENTIFICATION:

White size 0 veggie-capsules with brown powder.

PRESENTATION:

White HDPE labelled bottle with 60 capsules.

STORAGE INSTRUCTIONS:

Store at or below 25º C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER/APPLICATION NUMBER:

This medicine has not been evaluated by the South African Health Products Regulatory Authority. This medicine is not intended to diagnose, treat, cure or prevent any disease

NAME AND BUSINESS ADDRESS OF APPLICANT:

New Age Africa

Postnet Suite 152

Private Bag X1

Glenvista

Gauteng

2053

0800 172 963

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

April 2021

DISCIPLINE OF THE MEDICINE

Disciple-Specific Traditional – Combination Product

REFERENCES

American Journal of Health-System Pharmacy; 1999; 56: 125-38

Phytotherapeutics; 2001; 8: 922-6

Upton R; Ashwagandha Root (Withania somnifera); Analytical, quality control, and therapeutic monograph; Santa Cruz, CA; American Herbal Pharmacopoeia; 2001: 1-25