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| NDC | 64471-126-48 |
| Set ID | f6876cd5-4353-48bd-b1bf-610c928bcb1b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Source Naturals, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
In case of overdose, get medical help or contact a Poison Control Center right away.
A high fever may be the sign of a serious health condition. If fever or ear pain persist for more than 2 days or new symptoms occur, consult a physician.
As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a physician before using this product.
Keep this and all medicines out of the reach of children.
Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number.
Contains Milk.
- KEEP OUT OF REACH OF CHILDREN:
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DIRECTIONS:
Chew 1 tablet slightly and let it dissolve in the mouth. For infants, crush a tablet between two spoons, add water or juice if desired, and place in mouth. Repeat every 2 to 4 hours as needed, for up to 48 hours. For optimal results take 3-4 doses per day.
One or two doses per day may be taken for up to 4 weeks if symptoms recur or do not resolve completely.
Give Wellness EarAche to children or infants over 6 months of age. This product is not recommended for use by infants under 6 months of age without the advice of your physician.
For Best Results: Keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. These substances may interfere with absorption.
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
WELLNESS EARACHE
capsicum annuum, silicea, verbascum thapsus, ferrum phosphoricum, kali muriaticum, aconitum napellus, belladonna, calcarea carbonica, pulsatilla (pratensis) tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64471-126 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 6 [hp_X] VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 6 [hp_X] FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 12 [hp_X] POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 12 [hp_X] ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 30 [hp_X] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X] PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS 30 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64471-126-48 2 in 1 CARTON 06/13/2018 1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/13/2018 Labeler - Source Naturals, Inc. (969024228) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(64471-126) , api manufacture(64471-126) , label(64471-126) , pack(64471-126)
