dr. reckeweg r16 cimisan

SPL v1

SPL

SPL Set ID e8045873-06cc-4614-b31d-27187bcbcb00

Route

oral

Published

Effective Date 2013-04-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

black cohosh (4 [hp_X]) gelsemium sempervirens root (3 [hp_X]) iris versicolor root (2 [hp_X]) sanguinaria canadensis root spigelia anthelmia

Inactive Ingredients

alcohol water

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 1986-06-01

Description

Active ingredients Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients

Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

Indications and Usage

Uses

For the temporary relief of:

Migraine headache pain

Dosage and Administration

Directions

Adults and children ≥ 12 years: acute cases: 5-10 drops (up to 6 times per day);

in chronic cases: 5-10 drops 3 times daily in a little water or undiluted or as recommended.

Description

Active ingredients Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

Section 51727-6

Inactive ingredients

Ethanol, purified water.

Section 51945-4

NDC# 53346-1316-5

Dr. Reckeweg R16 Cimisan

Homeopathic preparation for the temporary relief of:

Migraine headache pain

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1

Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9

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

Section 55105-1

Purpose

Relieves migraine headache pain

Section 60561-8

Other information

Tamper resistant: do not use if safety ring at base of cap is broken.
Retain outer carton for full product information.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients

Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g.

Indications and Usage (34067-9)

Uses

For the temporary relief of:

Migraine headache pain

Dosage and Administration (34068-7)

Directions

Adults and children ≥ 12 years: acute cases: 5-10 drops (up to 6 times per day);

in chronic cases: 5-10 drops 3 times daily in a little water or undiluted or as recommended.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol, purified water.

Section 51945-4 (51945-4)

NDC# 53346-1316-5

Dr. Reckeweg R16 Cimisan

Homeopathic preparation for the temporary relief of:

Migraine headache pain

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1 (53413-1)

Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Relieves migraine headache pain

Section 60561-8 (60561-8)

Other information

Tamper resistant: do not use if safety ring at base of cap is broken.
Retain outer carton for full product information.

Advanced Ingredient Data

[{"name": "BLACK COHOSH", "unii": "K73E24S6X9", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "unii": "639KR60Q1Q", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "IRIS VERSICOLOR ROOT", "unii": "X43D4L3DQC", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SANGUINARIA CANADENSIS ROOT", "unii": "N9288CD508", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "SPIGELIA ANTHELMIA", "unii": "WYT05213GE", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "50", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "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 For the temporary relief of: Migraine headache pain", "34068-7": "Directions Adults and children ≥ 12 years: acute cases: 5-10 drops (up to 6 times per day); in chronic cases: 5-10 drops 3 times daily in a little water or undiluted or as recommended.", "34071-1": "Warnings", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.", "51727-6": "Inactive ingredients Ethanol, purified water.", "51945-4": "NDC# 53346-1316-5 Dr. Reckeweg R16 Cimisan Homeopathic preparation for the temporary relief of: Migraine headache pain Manufactured by: Dr. Reckeweg Co. GmbH D-64625 Bensheim Germany 1.68 fl oz (50 ml)", "53413-1": "Questions? Call 1-800-361-7872 or email questions@reckeweg.com", "53414-9": "If pregnant or breastfeeding , ask a health care professional before use.", "55105-1": "Purpose Relieves migraine headache pain", "55106-9": "Active ingredients Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X, 1 g each in 10 g. ", "60561-8": "Other information Tamper resistant: do not use if safety ring at base of cap is broken. Retain outer carton for full product information."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:09:13.595500 · Updated: 2026-03-14T23:14:25.585257