Label: COLD BUSTER- pelargonium sidoides syrup
- NDC Code(s): 22955-016-20
- Packager: SiCap Industries LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Updated April 13, 2010
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- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
Directions: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 take 1 teaspoon (5ml)
12 years of age 3 times daily
Children 6 to 11: take 1 teaspoon (5ml)
2 times daily
Children under 6: Consult a doctor before use.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
PRINCIPAL DISPLAY PANEL
- Shortens duration and reduces severity of cold symptoms
- Loosens mucous
- Boosts the immune system
- Soothes and warms on contact
Unlike many remedies that simply mask symptoms, Cold Buster speeds recovery. The active ingredient in Cold Buster has been clinically shown to significantly reduce duration and severity of cold symptoms.
Powerful 3-way Effect:
- Attacks the cause of illness
- Speeds up the movement of mucus out of the respiratory tract
- Boosts the immune system
The active ingredient in Cold Buster is one of the most researched plant-based medicines available.
Warming Honey Lemon Syrup:
Provides an immediate soothing spread of warmth from your throat down into your chest.
Non-Drowsy, Zinc-Free Formula:
Can use any time of day with no unpleasant zinc aftertaste.
Made in the USA
Not tested on animals
SiCap LLC, Albany,
New York 12205,
a wholly owned subsidiary of Dynova Laboratories, Inc.
INGREDIENTS AND APPEARANCE
pelargonium sidoides syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22955-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 24 [hp_X] in 120 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22955-016-20 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2010 Labeler - SiCap Industries LLC (170665298) Registrant - SiCap Industries LLC (170665298) Establishment Name Address ID/FEI Business Operations SiCap Industries LLC 170665298 manufacture