sleepy time cp

SPL v2

SPL

SPL Set ID 03cbb408-7e2a-49e8-b83a-b8d932a10459

Route

oral

Published

Effective Date 2023-01-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

aconitum napellus (30 [hp_X]) arsenic cation (3+) oyster shell calcium carbonate, crude arabica coffee bean magnesium strychnos nux-vomica seed anemone pulsatilla sepia officinalis juice sulfur

Inactive Ingredients

citric acid monohydrate glycerin potassium sorbate water

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2018-04-30

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

Medication Information

Warnings and Precautions

WARNINGS:

IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Do not use if TAMPER EVIDENT seal is broken or missing.

Active Ingredient

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

Indications and Usage

USES: Temporarily relieves occasional sleeplessness.**

Dosage and Administration

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Description

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

Section 34093-5

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6

INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Natural Cherry Flavor, Potassium Sorbate, Purified Water

Section 51945-4

NDC:43406-0675-1

Sleepy Time CP

HOMEOPATHIC

1 fl oz (30mL) / Alcohol Free

Section 53413-1

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1

USES: Temporarily relieves occasional sleeplessness.**

Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS:

IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
Do not use if TAMPER EVIDENT seal is broken or missing.

Active Ingredient (55106-9)

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X

Indications and Usage (34067-9)

USES: Temporarily relieves occasional sleeplessness.**

Dosage and Administration (34068-7)

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

Section 34093-5 (34093-5)

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Natural Cherry Flavor, Potassium Sorbate, Purified Water

Section 51945-4 (51945-4)

NDC:43406-0675-1

Sleepy Time CP

HOMEOPATHIC

1 fl oz (30mL) / Alcohol Free

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

Section 55105-1 (55105-1)

USES: Temporarily relieves occasional sleeplessness.**

Advanced Ingredient Data

[{"name": "ACONITUM NAPELLUS", "unii": "U0NQ8555JD", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ARSENIC CATION (3+)", "unii": "C96613F5AV", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "MAGNESIUM", "unii": "I38ZP9992A", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ANEMONE PULSATILLA", "unii": "I76KB35JEV", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SEPIA OFFICINALIS JUICE", "unii": "QDL83WN8C2", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "USES: Temporarily relieves occasional sleeplessness.**", "34068-7": "DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.", "34071-1": "WARNINGS: IF PREGNANT OR BREAST-FEEDING , ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. Do not use if TAMPER EVIDENT seal is broken or missing.", "34093-5": "*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.", "50565-1": "KEEP OUT OF THE REACH OF CHILDREN . In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.", "51727-6": "INACTIVE INGREDIENTS: Citric Acid, Glycerin USP, Natural Cherry Flavor, Potassium Sorbate, Purified Water", "51945-4": "NDC:43406-0675-1 Sleepy Time CP HOMEOPATHIC 1 fl oz (30mL) / Alcohol Free", "53413-1": "QUESTIONS & COMMENTS? Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600", "55105-1": "USES: Temporarily relieves occasional sleeplessness.**", "55106-9": "ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aconitum 30X, Arsenicum Alb 30X, Calc Carb 30X, Coffea Cruda 30X, Magnesium Met 30X, Nux Vom 30X, Pulsatilla 30X, Sepia 30X, Sulphur 30X"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:09.698094 · Updated: 2026-03-14T23:17:34.098873