cold

cold
SPL v2
SPL
SPL Set ID c45d1d8f-24be-4c13-8c4b-388962421415
Route
oral
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
baptisia tinctoria (4 [hp_X]) echinacea angustifolia (6 [hp_X]) eupatorium perfoliatum flowering top (12 [hp_X]) lomatium dissectum root pueraria montana var. lobata whole trifolium pratense flower phytolacca americana root onion arsenic cation (3+) barium cation bromine oyster shell calcium carbonate, crude potassium cation lachesis muta venom mercurius solubilis silicon dioxide
Inactive Ingredients
alcohol water

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2019-02-07

Description

ACTIVE INGREDIENTS - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X


Medication Information

Warnings and Precautions

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • 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.
  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Active Ingredient

ACTIVE INGREDIENTS - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X

Indications and Usage

USES: Temporarily relieves symptoms associated with the common cold.**

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 - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X

Section 34093-5

**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: Ethyl Alcohol USP, Purified Water

Section 51945-4

NDC:43406-0688-1

Cold

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

USES: Temporarily relieves symptoms associated with the common cold.**


Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • 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.
  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.
Active Ingredient (55106-9)

ACTIVE INGREDIENTS - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X

Indications and Usage (34067-9)

USES: Temporarily relieves symptoms associated with the common cold.**

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)

**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: Ethyl Alcohol USP, Purified Water

Section 51945-4 (51945-4)

NDC:43406-0688-1

Cold

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

USES: Temporarily relieves symptoms associated with the common cold.**


Advanced Ingredient Data


Raw Label Data

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