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NDC 53499-0193-05 Cough and Bronchial with Zinc 8; 3; 4; 3; 4; 3; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL Details

Cough and Bronchial with Zinc 8; 3; 4; 3; 4; 3; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL

Cough and Bronchial with Zinc is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Schwabe North America, Inc. The primary component is ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; ZINC GLUCONATE.

Product Information

NDC	53499-0193
Product ID	53499-0193_f542d6c4-d43d-4010-a319-7c86e4b2d518
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cough and Bronchial with Zinc
Proprietary Name Suffix	n/a
Non-Proprietary Name	ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, SPONGIA OFFICINALIS SKELETON, ROASTED, ZINC GLUCONATE
Product Type	HUMAN OTC DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	8; 3; 4; 3; 4; 3; 1
Active Ingredient Units	[hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL
Substance Name	ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; ZINC GLUCONATE
Labeler Name	Schwabe North America, Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 53499-0193-05 (53499019305)

Pricing Information	N/A
NDC Package Code	53499-0193-5
Billing NDC	53499019305
Package	1 BOTTLE, PLASTIC in 1 BOX (53499-0193-5) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2004-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 10ba549e-c532-4375-860f-5c499ea59479 Details

Active Ingredients

ANTIMONIUM SULPHURATUM AUREUM 8X

BRYONIA 3X

DROSERA 4X

EUCALYPTUS GLOBULUS 3X

IPECACUANHA 3X

SPONGIA TOSTA 3X

ZINCUM GLUCONICUM 1X

Inactive Ingredients

Ethyl Alcohol

Fructose

Glycerin

Purified Water

Dosage & Administration

Shake well before use.

Adults and children 12 years and older: Take 1-2 teaspoons (tsp) (5-10 mL) every 4 to 6 hours.

Do not exceed 12 teaspoons in a 24 hour period.

Children under 12 years of age: Consult a doctor.

Purpose

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Indications & Usage

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Warning

Do not use this product fore persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where coughis accompanied by excessive phlegm (mucus).

Ask doctor

Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema or is accompanied by excessive phlegn (mucus).

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, if cough is accompanied by a fever, rash, or persistent headache.

These could be signs of a serious condition.

Pregnancy or breast feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out reach of children

Keep out of reach of children.

Overdose

In case of overdose, seek medical help or contact Posion Control Center immeditely.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH AND BRONCHIAL WITH ZINC

antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, spongia officinalis skeleton, roasted, zinc gluconate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-0193
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANTIMONY PENTASULFIDE (UNII: 1433F1I86N) (ANTIMONY PENTASULFIDE - UNII:1433F1I86N)	ANTIMONY PENTASULFIDE	8 [hp_X] in 237 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X] in 237 mL
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	4 [hp_X] in 237 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	3 [hp_X] in 237 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	4 [hp_X] in 237 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X] in 237 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X] in 237 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-0193-9	1 in 1 BOX	07/01/2004	04/30/2024
1		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:53499-0193-5	1 in 1 BOX	07/01/2004	03/31/2024
2		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2004	04/30/2024

Labeler - Schwabe North America, Inc (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-0193)

Revised: 8/2022

Document Id: f542d6c4-d43d-4010-a319-7c86e4b2d518

Set id: 10ba549e-c532-4375-860f-5c499ea59479

Version: 9

Effective Time: 20220801