Label: ZINC COLD THERAPY- zinc gluconate tablet, chewable
- NDC Code(s): 21130-881-25
- Packager: BETTER LIVING BRANDS 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 February 12, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
may help reduce duration and severity of cold symptoms
- sore throat
- stuffy nose
- This product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison ControlCenterright away at 1-800-222-1222
- For best results, use at the first sign of a cold and continue to use as directed
adults and children 12 years of age and older:
- chew one tablet at the onset of symptoms
- repeat every 3 hours until symptoms are gone
- to avoid minor stomach upset, do not take on an empty stomach.
- do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids
- recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17
- Children under 12 years of age: Consult a doctor before use.
- Other information
- do not take zinc tablets on an empty stomach to avoid possible minor stomach upset.
- store at room temperature
- Inactive ingredients
ascorbic acid, crospovidone, FD&C yellow # 6 lake, magnesium stearate, natural and artificial flavor sorbitol, starch, sucraloseClose
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
*COMPARE TO Zicam® Cold Remedy Rapidmelts®* Ionizable Zinc Content*
Signature Care ™
Zinc Cold Therapy
Naturally and Artificially Flavored
- Sugar Free Homeopathic†
25 CHEWABLE TABLETS
DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING
†THIS PRODUCT IS A HOMEOPATHIC REMEDY, AS SUCH, IT HAS NOT UNDERGONE REVIEW OR APPROVAL BY THE FDA AND THEREFORE HAS NOT BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE TO DIAGNOSE, TREAT, PREVENT, MITIGATE OR CURE ANY CONDITION OR DISEASE.
†CLAIM IS BASED ONLY ON THEORIES OF HOMEOPATHY FROM 1700S NOT ACCEPTED BY MOST MODERN MEDICAL EXPERTS .THERE IS NO SCIENTIFIC EVIDENCE THAT THE PRODUCT WORKS
IMPORTANT:Keep this carton for future reference on full labeling.
*This product is not manufactured or distributed by Matrixx Initiatives, Inc, owner of the registered trademarks Zicam® Cold Remedy Rapidmelts® .
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O BOX 99, PLEASANTON, CA 94566-0009
- INGREDIENTS AND APPEARANCE
ZINC COLD THERAPY
zinc gluconate tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-881 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 1 [hp_X] Inactive Ingredients Ingredient Name Strength ascorbic acid (UNII: PQ6CK8PD0R) crospovidone (UNII: 68401960MK) FD&C Yellow No. 6 (UNII: H77VEI93A8) magnesium stearate (UNII: 70097M6I30) SORBITOL (UNII: 506T60A25R) STARCH, CORN (UNII: O8232NY3SJ) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color ORANGE Score no score Shape ROUND (Biconcave) Size 16mm Flavor CITRUS Imprint Code r8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-881-25 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 02/28/2018 Labeler - BETTER LIVING BRANDS LLC (009137209)