Cold Flu Relief Orange Tablet, Chewable
FDA Label NDC 53499-0161

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc. for the product Cold Flu Relief Orange (NDC 53499-0161). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, dosage & administration, indications & usage, purpose, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Pelargonium sidoides 1X

Aconitum napellus 4X

Eucalyptus globulus 2X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X

Phosphorus 6X

Ipecacuanha 3X

Inactive Ingredients

Citric Acid

Lactose Monohydrate

Magnesium Stearate

Malic Acid

Maltodextrin

Mannitol

Natural Flavor

Sorbitol

Stearic Acid

Xylitol

Dosage & Administration

Directions:

Chew or dissolve tablets in the mouth. Do not swallow whole.

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

Adults & children 13 years of age and older: Take 1 chewable tablet three times daily.
Children 6-12 years of age: Take 1 chewable tablet 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, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat. 

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations, and temporarily relieves flu symptoms: chills/fever, chest congestion, nasal congestion, cough, headache, hoarseness, body aches, sneezing/runny nose, sore throat.

Warnings

Sore throat warning: if sore throat is severe, persists for 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 accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae 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 signs of a serious condition.

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.

Overdose

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

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