Cold Relief Lemon
Cold Relief Lemon Hot Drink
f5c9b1c4-dbc6-4fa3-bc41-4ee4bf417eb5
HUMAN OTC DRUG LABEL
Jul 31, 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.
Pelargonium sidoides
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Pelargonium sidoides 1X
Inactive Ingredients
Citric Acid
Maltodextrin
Natural Flavor
Silica
Turmeric Color
Xylitol
DOSAGE & ADMINISTRATION SECTION
Dosage & Administration
Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.
May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.
For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults and children 13 years of age and older: Take 1 packet three times daily.
Children 6-12 years of age: Take 1 packet two times daily.
Children under 6 years of age: Consult a doctor.
Indications & Usage
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Purpose
Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
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 Geraniaceae 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 signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Pregnant 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.
OVERDOSAGE SECTION
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.