Cough Relief
Cough Relief
a95610e3-774b-4745-a2a4-fc3ba51ab4c5
HUMAN OTC DRUG LABEL
Sep 16, 2025
Schwabe North America, Inc.
DUNS: 831153908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cough Relief
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Pelargonium sidoides 1X
Aconitum napellus 3X
Bryonia 3X
Hepar sulphuris calcareum 6C
Stannum metallicum 6C
Spongia tosta 3X
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Citric Acid
English Ivy Leaf Extract
Ethyl Alcohol
Glycerin
Lactose Monohydrate
Maltodextrin
Potassium Sorbate
Purified Water
Sorbitol
OTC - PURPOSE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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.
OTC - ASK DOCTOR SECTION
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.
OTC - STOP USE SECTION
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.
OVERDOSAGE SECTION
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Keep out of reach of children.