HAN HONEY LOQUAT SYRUP- menthol syrup
PRINCE OF PEACE ENTERPRISES INC.

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.

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Han’s Honey Loquat Syrup

Menthol 0.1%......................................Oral Pain Reliever

Uses For the temporary relief of pain

due to minor irritation of the mouth and gumsdue to minor irritation of the mouth and gums

due to sore mouth

due to sore throat

Do not exceed recommended dosage

Stop use and ask a doctor if

sore throat is severe or persists for more than 2 days, or is accompanied by high fever, headache, rash, swelling, nausea, or vomiting

sore mouth symptoms do not improve in 7 days

irritation, pain, or redness persists or worsens

Children under 3 years of age

Do not use otherwise than as directed

Keep this and all drugs out of reach of children.

In the case of accidental overdose, seek professional assistance or contact a poison control center immediately.

If pregnant or breast-feeding, ask a health professional before use.

Directions


Adults and children 12 years of age and older	Take 2 teaspoonful every 4 to 6 hours or as directed by a doctor.
Children over 3 years of age	Take 1 teaspoonful every 4 to 6 hours or as directed by a doctor.
Children under 3 years of age	Not recommended

store at cool room temperature, less than 20°C (less than 68°F)

-510-887-1899 Monday to Friday, 8am - 5pm Pacific Standard Time
www.popus.com

Maltose, Honey, Loquat leaf, Grosvenor Momordica fruit, Fritillary bulb, Stemona root, Bitter Apricot seed, Hogfennel root, Licorice root

PPD of label

HAN HONEY LOQUAT SYRUP
menthol syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62003-888
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MALTOSE (UNII: XJ6S9RV06F)
HONEY (UNII: Y9H1V576FH)
ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
FRITILLARIA CIRRHOSA BULB (UNII: 1MIE9LPB5I)
STEMONA SESSILIFOLIA ROOT (UNII: EKG8030U4N)
PEUCEDANUM PRAERUPTORUM ROOT (UNII: I5C2RXT7C1)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62003-888-86	6 in 1 BOX
1	NDC:62003-888-85	252 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/01/2014

Labeler - PRINCE OF PEACE ENTERPRISES INC. (131132714)

Name	Address	ID/FEI	Business Operations
Establishment
Tianjin Zhongyi Pharmaceutical Co Ltd		421684143	manufacture(62003-888)

Revised: 4/2014

Document Id: 31f96d1d-f2a0-491c-80a5-f527885c0c4b

Set id: 50bbf038-0667-4286-adde-619ce9406da7

Version: 1

Effective Time: 20140426

PRINCE OF PEACE ENTERPRISES INC.