Label: COLD- aconitum napellus, allium cepa, gelsemium semp., zincum gluconicum tablet
- NDC Code(s): 54973-3010-1
- Packager: Hyland's Inc.
- 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.
Drug Label Information
Updated December 7, 2022
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- PURPOSE
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Drug Facts
Active ingredients Purpose Aconitum Napellus 6X HPUS sneezing, watery eyes, sore throat Allium Cepa 6X HPUS red/watery eyes, runny nose, nasal discharge Gelsemium Sempervirens 6X HPUS sneezing, headache, sore throat, cough Zincum Gluconicum 2X HPUS runny nose, sore throat "HPUS" indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States. - Uses
-
Warnings
Consult a physician if:
■ symptoms persist for more than 7 days or worsen.
■ inflammation, fever (over 101°F) or infection is present or develops.
■ cough tends to recur or is accompanied by a fever (over 101°F), rash or persistent headache.Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional.
- Directions
- Drug Facts (continued)
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL- PRINCIPAL DISPLAY PANEL
HOMEOPATHIC
NDC 54973-3010-1AGES 6+
SINCE 1903
Hyland's
Cold Tablets
with Zinc*
SHORTENS
COLDS
MULTI - SYMPTOM RELIEF
Relieves Runny Nose, Congestion, Sore Throat,
Cough, Sneezing, Headache and FeverFree of Dyes and Preservatives
Non-Drowsy50 QUICK-DISSOLVING
TABLETS
NATURAL
RELIEF
*SEE NOTE ON SIDE PANEL BELOW DRUGS FACTS
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INGREDIENTS AND APPEARANCE
COLD
aconitum napellus, allium cepa, gelsemium semp., zincum gluconicum tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 6 [hp_X] in 1 g GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 g ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 g ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3010-1 1 in 1 CARTON 02/17/1997 1 1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/17/1997 Labeler - Hyland's Inc. (008316655)