Drugplain

Cough Syrup 30 [hp_C]/mL

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.

8 Recalls on Record
Plain English

Cough Syrup is a syrup containing camphor (natural), arsenic trioxide, bryonia alba root, drosera rotundifolia, ipecac, potassium carbonate, phosphorus, anemone pulsatilla, spongia officinalis skeleton, roasted, drimia maritima whole at 30 [hp_C]/mL, taken oral. Manufactured by Natural Creations, Inc..

Key Facts

Brand Name
Cough Syrup
Generic Name
Camphor (Natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole
NDC Code (Product)
43406-0664
Manufacturer
Natural Creations, Inc.
Strength
30 [hp_C]/mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Marketing Start
05/07/2007

Recall History

8 Recalls on Record
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/15/2018

MBi Distributing Inc. dba MBi Nutraceuticals

Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/02/2019

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class III08/14/2012

Actavis Mid Atlantic LLC

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

TerminatedVoluntary: Firm initiated
Class II05/02/2019

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II09/23/2019

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug abuse111 reports
cough34 reports
pneumonia27 reports
cardiac arrest23 reports
death23 reports
dyspnoea23 reports
respiratory arrest23 reports
drug ineffective22 reports
nausea22 reports
completed suicide21 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Formula 3 Cough Syrup Temprarily relieves symptoms of cough including dryness and minor throat and bronchial irritation associated with the common cold.

Dosage & Administration

Formula 3 Cough Formula - Children 2 to 4 years of age: 1/2 teaspoon every 3 hours, or as needed. - Children 5 to 11 years of age: 1 teaspoon every 3 hours, or as needed. Children under 2 years of age: Consult your healthcare practitioner

Warnings

Formula 3 Cough Syrup Do not give product for persistent or chronic cough such as occurs with asthma or if cough is accompanied excessive phlegm (mucus) unless directed by doctor. Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may be a sign of a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Cough Syrup used for?

Cough Syrup contains Camphor (Natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole. It is a syrup taken oral. Consult your doctor for specific uses.

Is Cough Syrup a controlled substance?

Cough Syrup is not classified as a controlled substance by the DEA.

What is the generic name for Cough Syrup?

The generic name for Cough Syrup is Camphor (Natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole. There are no other listed brand versions of Camphor (Natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole.

What is the NDC code for Cough Syrup 30 [hp_C]/mL?

The NDC (National Drug Code) for Cough Syrup 30 [hp_C]/mL is 43406-0664, listed by Natural Creations, Inc..

Product NDC

43406-0664

Package NDC

43406-0664-4

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)