Label: SNIFFLES N SNEEZES 4 KIDS- aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate tablet
- NDC Code(s): 54973-3160-1
- 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 14, 2022
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredients
Active ingredients Purpose Acontitum 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 Gluconium 2X HPUS runny nose and sore throat
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Consult a physician if:
- symptoms persist for more than 7 days or worsen.
- inflammation, fever or infection develops.
- symptoms are accompanied by a high fever (over 101°F).
- cough tends to recur or is accompanied by a high fever, rash or persistent headache.
Keep this and all medications out of the reach of children.
In case of accidental overdose, contact a medical professional or a poison control center immediately.
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 health care professional.
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Drug Facts (continued)
Directions
Children 2 years to under 6 years dissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Children 6 years to under 12 years dissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Adults and children 12 years and over dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required - Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
SNIFFLES N SNEEZES 4 KIDS
aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3160 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 6 [hp_X] ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 2 [hp_X] 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:54973-3160-1 1 in 1 CARTON 06/10/2013 1 125 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 06/10/2013 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3160) , pack(54973-3160)