<<

ZICAM COLD REMEDY RAPIDMELTS CITRUS- acetate anhydrous and tablet Matrixx Initiatives, Inc. 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 as effective. ------® Zicam® Cold Remedy Rapidmelts Citrus Drug Facts

Active ingredients (in each tablet) Zincum aceticum 2x Zincum gluconicum 1x

Purpose Reduces duration and severity of the

Uses reduces duration of the common cold helps reduce severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion

Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Warnings Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: take 1 tablet at the onset of symptoms dissolve entire tablet in mouth. Do not chew. Do not swallow whole. repeat every 2–3 hours, not to exceed 7 tablets in 24 hours. Take 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. children under 12 years of age: ask a doctor before use

Other information store between 15-29°C (59-84°F)

Inactive ingredients ascorbic acid, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, mannitol, mono- ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose

Questions? Comments? Side Effects? call 877-942-2626 toll free Distributed by Matrixx Initiatives, Inc. Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton CLINICALLY PROVEN TO SHORTEN COLDS GREAT TASTING! RAPIDMELTS® Citrus Flavor 25 Quick Dissolve TABLETS HOMEOPATHIC

ZICAM COLD REMEDY RAPIDMELTS CITRUS zinc acetate anhydrous and zinc gluconate tablet

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 2750 -0 44

Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC ACETATE ANHYDRO US (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 2 [hp_X] ZINC GLUCO NATE (UNII: U6 WSN5SQ1Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC GLUCONATE 1 [hp_X]

Inactive Ingredients Ingredient Name Strength a sco rbic a cid (UNII: PQ6 CK8 PD0 R) cro spo vido ne (15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK) FD&C Yello w No . 6 (UNII: H77VEI9 3A8 ) a luminum o xide (UNII: LMI26 O6 9 33) ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 ) ma nnito l (UNII: 3OWL53L36 A) a mmo nium g lycyrrhiza te (UNII: 3VRD35U26 C) stea ric a cid (UNII: 4ELV7Z6 5AP) sucra lo se (UNII: 9 6 K6 UQ3ZD4) so dium sta rch g lyco la te type A po ta to (UNII: 58 56 J3G2A2)

Product Characteristics Color ORANGE (Speckled) Score no sco re Shape ROUND (cup shaped) Siz e 15mm Flavor CITRUS Imprint Code Z Contains

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:6 2750 -0 44- 1 1 in 1 CARTON 10 /0 1/20 11 10 25 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 1 Pro duct NDC:6 2750 -0 44- 2 1 in 1 CARTON 10 /0 1/20 11 11 45 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 2 Pro duct NDC:6 2750 -0 44- 3 1 in 1 CARTON 0 4/0 6 /20 16 12 3 5 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct NDC:6 2750 -0 44- 4 1 in 1 CARTON 0 7/27/20 18 14 56 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 4 Pro duct NDC:6 2750 -0 44- 5 1 in 1 CARTON 0 6 /10 /20 19 16 12 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n 5 Pro duct

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date UNAPPROVED HOMEOPATHIC 10 /0 1/20 11

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment Name Addre ss ID/FEI Busine ss Ope rations LNK Internatio nal, Inc. 8 33150 8 0 3 MANUFACTURE(6 2750 -0 44)

Establishment Name Addre ss ID/FEI Busine ss Ope rations LNK Internatio nal, Inc. 9 6 76 26 30 5 MANUFACTURE(6 2750 -0 44) , PACK(6 2750 -0 44)

Establishment Name Addre ss ID/FEI Busine ss Ope rations LNK Internatio nal, Inc. 8 6 8 7340 8 8 MANUFACTURE(6 2750 -0 44) , PACK(6 2750 -0 44)

Establishment Name Addre ss ID/FEI Busine ss Ope rations LNK Internatio nal, Inc. 0 38 15446 4 MANUFACTURE(6 2750 -0 44) , PACK(6 2750 -0 44)

Establishment Name Addre ss ID/FEI Busine ss Ope rations LNK Internatio nal, Inc. 8 328 6 78 37 MANUFACTURE(6 2750 -0 44) , PACK(6 2750 -0 44)

Establishment Name Addre ss ID/FEI Busine ss Ope rations Nutritio nal Labs Internatio nal 6 0 79 179 9 9 REPACK(6 2750 -0 44)

Revised: 4/2020 Matrixx Initiatives, Inc.