Label: 4 KIDS STUFFY NOSE AND SINUS- pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tablet
- NDC Code(s): 54973-3406-1, 54973-3406-2
- 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 March 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
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Drug Facts
Active ingredients
Active ingredients Purpose Calcarea Carbonica 3X HPUS sinus pressure, congestion, headache Hydrastis Canadensis 6X HPUS sinus headache Kali Bichromicum 6X HPUS nasal congestion, sinus pressure Pulsatilla Nigricans 6X HPUS sinus pressure, headache "HPUS" is the Homeopathic Pharmacopoeia of the United States.
- Uses
- Warnings
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Directions
■ Use as directed.
Children 2 years
to under 6 yearsAt onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist,
1 tablet every 4 hours until relieved.Children 6 years
to under 12 yearsAt onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist,
2 tablets every 4 hours until relieved.Adults and children
12 years and overAt onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours. If symptoms persist,
3 tablets every 4 hours until relieved. - Inactive ingredients
- Questions?
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
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INGREDIENTS AND APPEARANCE
4 KIDS STUFFY NOSE AND SINUS
pulsatilla pratensis whole,oyster shell calcium carbonate, crude,goldenseal and potassium dichromate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3406 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 3 [hp_X] GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 6 [hp_X] PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 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:54973-3406-1 1 in 1 CARTON 01/27/2020 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3406-2 1 in 1 CARTON 01/27/2020 03/06/2023 2 16 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 01/27/2020 Labeler - Hyland’s Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3406) , pack(54973-3406) , label(54973-3406)
