FDA.reportPublic FDA data

Cough Syrup

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:24

Label at a glance#

ProductCough Syrup
Active ingredientCAMPHOR (NATURAL), ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, ANEMONE PULSATILLA, SPONGIA OFFICINALIS SKELETON, ROASTED, DRIMIA MARITIMA WHOLE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

OTC - PURPOSE SECTION

USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health 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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

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

REFERENCES SECTION

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

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0664-4

COUGH SYRUP

HOMEOPATHIC

Natural Cherry / Mixed Berry Flavor

4 fl oz (120 mL)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0664-42023-01-10C16284748780-1d6a99b39-ba46-a426-e053-dadaa90af4c2COUGH SYRUP
43406-0664-42022-01-28C16284748780-1d6a99b39-ba46-a426-e053-dadaa90af4c2COUGH SYRUP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0664-4Cough Syrup120 mL in 1 BOTTLE, PLASTICSYRUP1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0664COUGH SYRUP (CAMPHOR (NATURAL), ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, ANEMONE PULSATILLA, SPONGIA OFFICINALIS SKELETON, ROASTED, DRIMIA MARITIMA WHOLE) SYRUP [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20230111_285230d6-96b7-4bab-8347-c7b10a3c0ebb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-066443406-0664-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
IPECAC62I3C8233LACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
DRIMIA MARITIMA WHOLEUNM4C1735ZACTIB
ACACIA5C5403N26OIACT
ANISE OIL6Y89129C8HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
CHAMOMILEFGL3685T2XIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
CETRARIA ISLANDICA SUBSP. ISLANDICABJ7YPN79A1IACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
MULLEIN LEAF9936O846LIIACT
MUSA X PARADISIACA LEAF2UIJ27N6EDIACT
RED CLOVERL9153EKV2YIACT
URTICA DIOICA LEAFX6M0DRN46QIACT
THYMECW657OBU4NIACT
HONEYY9H1V576FHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough SyrupCAMPHOR (NATURAL), ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, ANEMONE PULSATILLA, SPONGIA OFFICINALIS SKELETON, ROASTED, DRIMIA MARITIMA WHOLENatural Creations, Inc.285230d6-96b7-4bab-8347-c7b10a3c0ebb2022-12-19WarningsExact identifier
ndc (package): 43406-0664-4
ndc (product): 43406-0664
ndc11 (package): 43406066404
spl id: c6b3d70d-2a1b-4065-91c0-f07fbfa0a1bb
spl set id: 285230d6-96b7-4bab-8347-c7b10a3c0ebb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.