Cough Baby

Ipecac, Bryonia Alba Root, Spongia Officinalis Skeleton, Roasted, Phosphorus, Causticum, Drosera Rotundifolia, And Rumex Crispus Root

Hyland's Inc.
Human Otc Drug
NDC 54973-3154

Cough Baby also known as Ipecac, Bryonia Alba Root, Spongia Officinalis Skeleton, Roasted, Phosphorus, Causticum, Drosera Rotundifolia, And Rumex Crispus Root is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Cough Baby is 54973-3154. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Cough Baby drug includes Bryonia Alba Root - 6 [hp_X]/mL Causticum - 6 [hp_X]/mL Drosera Rotundifolia - 6 [hp_X]/mL Ipecac - 6 [hp_X]/mL Phosphorus - 12 [hp_X]/mL Rumex Crispus Root - 6 [hp_X]/mL Spongia Officinalis Skeleton, Roasted - 6 [hp_X]/mL . The currest status of Cough Baby drug is Active.

Drug Information:

Drug NDC:	54973-3154
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Cough Baby
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Ipecac, Bryonia Alba Root, Spongia Officinalis Skeleton, Roasted, Phosphorus, Causticum, Drosera Rotundifolia, And Rumex Crispus Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hyland's Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Syrup
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BRYONIA ALBA ROOT - 6 [hp_X]/mL CAUSTICUM - 6 [hp_X]/mL DROSERA ROTUNDIFOLIA - 6 [hp_X]/mL IPECAC - 6 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL RUMEX CRISPUS ROOT - 6 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED - 6 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	17 Oct, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hyland's Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	T7J046YI2B DD5FO1WKFU QR44N9XPJQ 62I3C8233L 27YLU75U4W 9N1RM2S62C 1PIP394IID
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
54973-3154-2	118 mL in 1 BOTTLE (54973-3154-2)	17 Oct, 2012	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Cough Baby

Ipecac & more..

Syrup
Hyland's Inc.
NDC: 54973-3154

Purpose:

Relieves coughs in babies

Product Elements:

Cough baby ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root licorice water sodium benzoate glycerin citric acid monohydrate ipecac ipecac bryonia alba root bryonia alba root spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted phosphorus phosphorus causticum causticum drosera rotundifolia drosera rotundifolia rumex crispus root rumex crispus root

Indications and Usage:

Uses â temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

Warnings:

Warnings ask a doctor before use if you have: â persistent or chronic cough such as asthma, chronic bronchitis or emphysema. a persistent cough may be a sign of a serious condition. â cough that is accompanied by excessive phlegm (mucus). stop use and ask a doctor if: â symptoms persist for more than 72 hours or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache. keep out of reach of children. keep this and all medications out of the reach of children.

Dosage and Administration:

Directions â use as directed. â do not refrigerate. â shake well before using. ï® measure only with the dosing syringe provided. â do not use dosing syringe with other products. â on dosing syringe, ml = milliliter. children under 6 months ask a doctor before use. children 6 months to under 1 year 2.5 ml up to 4 times per day (every 6 hours). children 1 year to under 3 years 5 ml up to 6 times per day (every 4 hours).

Stop Use:

Stop use and ask a doctor if: â symptoms persist for more than 72 hours or worsen. â inflammation, fever or infection is present or develops. â cough tends to recur or is accompanied by a fever, rash or persistent headache.

Package Label Principal Display Panel:

Package label-118 ml bottle carton hyland's naturalsâ¢ â¢babyâ¢ cough syrup* daytime no alcohol, sugar, parabens or dyes 6+ months 4 fl. oz. (118 ml) homeopathic carton

Further Questions:

Questions? (800) 624-9659

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.