NIN JIOM PEI PA KOA - elm bark syrup NIN JIOM MEDICINE MANUFACTORY (HK) LTD Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ------Product Facts King to Nin Jiom Pei Pa Koa is a pleasant tasting natural herbal based liquid especially formulated for relief of minor discomfort and to protect irritated areas in sore mouth and sore throat. Pei Pa Koa contains No Alcohol, artificial flavors, colors, or preservatives.

INDICATIONS For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

DIRECTIONS: Adults and Children 2 years of age and older: 2 teaspoonfuls every 2 hours as needed or as directed by a doctor or dentist. Children under 2 years of age: Consult a doctor or dentist.

WARNINGS If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Keep this and all drugs out of the reach of children. Keep this and all drugs out of the reach of children.

Active: Elm Bark 650 mg per teaspoon.

In a Sucrose Syrup and Honey base of herbal extracts consisting of: loquat , fritillary, balloon root, snakegourd , sand root, senega root, tuckahoe, licorice root, ginger root, five flavored seed, and peppermint. For the temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Product Label NIN JIOM PEI PA KOA elm bark syrup

Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:5770 8 -8 8 8 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELM (UNII: 6 3POE2M46 Y) (ELM - UNII:6 3POE2M46 Y) ELM 6 50 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SUCRO SE (UNII: C151H8 M554) PLATYCO DO N GRANDIFLO RUM LEAF (UNII: 2L6 4H2X8 DY) PRZEWALSKII BULB (UNII: 8 B26 9 H8 XVH) ERIO BO TRYA JAPO NICA LEAF (UNII: Z0 20 6 6 SV11) GLEHNIA LITTO RALIS RO O T (UNII: 75447U56 MI) HO NEY (UNII: Y9 H1V576 FH) PO LYGALA SENEGA RO O T (UNII: M7T6 H7D4IF) GREATER GALANGAL (UNII: 7Y6 4R8 56 MB) LICO RICE (UNII: 6 1ZBX548 8 3) GINGER (UNII: C5529 G5JPQ) PEPPERMINT (UNII: V9 5R5KMY2B) FU LING (UNII: XH37TWY5O4) SCHISANDRA CHINENSIS FRUIT (UNII: ABS79 46 8 1C) TRICHO SANTHES CUCUMERINA SEED (UNII: O6 375G8 6 9 C)

Product Characteristics Color black Score Shape Siz e Flavor HONEY (Herbal Ho ney Lo quat Flavo red) Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:5770 8 -8 8 8 -0 2 24 in 1 CARTON 1 NDC:5770 8 -8 8 8 -0 1 30 0 mL in 1 BOTTLE, GLASS 2 NDC:5770 8 -8 8 8 -0 4 48 in 1 CARTON 2 NDC:5770 8 -8 8 8 -0 3 150 mL in 1 BOTTLE, GLASS

Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part356 0 9 /0 1/20 0 6

Labeler - NIN JIOM MEDICINE MANUFACT ORY (HK) LT D (686152166)

Establishment Name Addre ss ID/FEI Busine ss Ope rations NIN JIOM MEDICINE MANUFACTORY (HK) LTD 6 8 6 15216 6 manufacture

Revised: 3/2011 NIN JIOM MEDICINE MANUFACTORY (HK) LTD