Nativeremedies® Sleepy Jr.™

Nativeremedies® Sleepy Jr.™
SPL v1
SPL
SPL Set ID 4d11cc46-3939-1561-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cinchona Officinalis Bark (30 [hp_C]) Strychnos Nux-vomica Seed (6 [hp_C]) Matricaria Recutita Coffea Arabica Fruit Artemisia Cina Flower
Inactive Ingredients
Potassium Sorbate Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-04-24

Description

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.


Medication Information

Description

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.

Uses*:

Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Section 50565-1

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4

Section 53414-9

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

Section 55105-1

Relieves occasional sleeplessness & restlessness in toddlers & children

Section 60561-8

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. Fore more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Alternatively, the spray may be dispensed into a little water or juice. Use every night 15 minutes before bedtime until a regular sleep pattern is established. Repeat up to 3 times during the night if necessary. Children 18 months to 3 years: 1 pump spray. Chidlren over 3 years: 2 pump sprays.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Hpus Active Ingredients:

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.


Structured Label Content

Uses*:

Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Section 50565-1 (50565-1)

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Relieves occasional sleeplessness & restlessness in toddlers & children

Section 60561-8 (60561-8)

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. Fore more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Alternatively, the spray may be dispensed into a little water or juice. Use every night 15 minutes before bedtime until a regular sleep pattern is established. Repeat up to 3 times during the night if necessary. Children 18 months to 3 years: 1 pump spray. Chidlren over 3 years: 2 pump sprays.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

Hpus Active Ingredients: (HPUS Active Ingredients:)

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.


Advanced Ingredient Data


Raw Label Data

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