COUGH RELIEF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT- cough relief syrup 
Schwabe North America, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Cough Relief

Active Ingredients

Pelargonium sidoides 1X

Aconitum napellus 3X

Bryonia 3X 

Hepar sulphuris calcareum 6C

Stannum metallicum 6C

Spongia tosta 3X

Inactive Ingredients

Citric Acid

English Ivy Leaf Extract

Ethyl Alcohol 

Glycerin

Lactose Monohydrate

Maltodextrin

Potassium Sorbate

Purified Water

Sorbitol

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.

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

Indications & Usage 

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, cough, hoarseness, sore throat, nasal congestion.

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

Doage & Administration

Directions

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Shake well before each use.

Use only with enclosed dosage cup.

Adults and Children 13 years of age and older:  Take 1 ½ teaspoons (tsp) (7.5 mL) three times daily.

Children 6 to 12 years of age:  Take 1 teaspoon (5 mL) three times daily.

Children under 6 years of age: Consult a doctor.

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Genaniaceae family.

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be a sign of a serious condition.

Overdose

In case of overdose, seek medical help or contact a Poison Control Center right away.

Pregnancy or Breast Feeding

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

Keep out of reach of children

Keep out of reach of children.  

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COUGH RELIEF  ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
cough relief syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6864
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 120 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 120 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 120 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN6 [hp_C]  in 120 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 120 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-6864-41 in 1 BOX01/19/2024
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/19/2024
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America831153908manufacture(53499-6864)

Revised: 1/2024
Document Id: d3027d2b-3056-4789-a191-2069b8ab277a
Set id: a95610e3-774b-4745-a2a4-fc3ba51ab4c5
Version: 1
Effective Time: 20240119
 
Schwabe North America, Inc.