Nativeremedies® Sleepy Jr.™

Nativeremedies® Sleepy Jr.™
SPL v3
SPL
SPL Set ID 81a22c7c-69a5-ea2a-e053-2991aa0a1a5c
Route
ORAL
Published
Effective Date 2019-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Strychnos Nux-vomica Seed (30 [hp_C]) Matricaria Chamomilla Flowering Top Oil (6 [hp_C]) Artemisia Cina Flower Coffea Arabica Fruit Cinchona Officinalis Bark
Inactive Ingredients
Water Anhydrous Lactose Acacia Magnesium Stearate Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-12-17

Description

HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Description

HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses*

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.

Section 51945-4

Section 53414-9

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

Section 55105-1

Relieves occasional sleeplessness & restlessness in toddler and children.

Section 60561-8

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seals intact.

Warnings

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

Directions: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.

Inactive Ingredients

Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.

Hpus Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C.

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


Structured Label Content

Uses*

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.

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 toddler and children.

Section 60561-8 (60561-8)

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seals intact.

Warnings

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

Directions: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.

Inactive Ingredients

Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.

Hpus Active Ingredients (HPUS Active Ingredients)

HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C.

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


Advanced Ingredient Data


Raw Label Data

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