YINCHIAO - acetaminophen and chlorpheniramine maleate tablet, film coated 
TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY

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.

----------

DRUG FACTS

Active ingredient (in each tablet)
Acetaminophen 162.5 mg
Chlorpheniramine maleate 1 mg

Purpose
Pain reliever-fever reducer
Antihistamine

Uses
temporarily relieves these symptoms due to a cold, the flu, or hay fever:
minor aches and pains headache
sore throat
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat
temporarily reduces fever

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
adult takes more than 24 tablets in 24 hours, which is the maximum daily amount for this product
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product
Do not give to children under 6 years of age unless directed by a doctor.

Do not use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
for pain for more than 10 days (for adults) or 5 days (for children)
for fever for more than 3 days

Ask a doctor before use if the user has
liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product
do not exceed recommended dosage
avoid alcoholic beverages
may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)
use caution when driving or operating machinery
may cause excitability especially in children

Stop use and ask a doctor if
sore throat is severe
sore throat persists for more than 2 days
sore throat is accompanied or followed by:
fever
headache
rash
nausea
vomiting
any of the following occurs (these could be signs of a serious condition):
pain or fever persists or gets worse or new symptoms occur
redness or swelling is present

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. Prompt medical attention is critical for adults as well as for children even if you do
not notice any signs or symptoms.

Directions
adults and children 12 years of age and older: 4 tablets every 4 to 6 hours, not to exceed 6 doses (24 tablets) in 24 hours, or as directed by a doctor
children 6 to under 12 years of age: 2 tablets every 4 to 6 hours, not to exceed 5 doses (10 tablets) in 24 hours, or as directed by a doctor
children under 6 years: consult a doctor of age

Other information
keep tightly sealed
store between 15º to 30º C (59º to 86º F)

Questions or Comments? (888) 221-3496 M-F 9 am to 5 pm
you may also use this number to report serious adverse events associated with the use of this product

Inactive ingredients
Scutellaria baicalensis root, platycodon grandiflorum leaf, arctium lappa fruit, mint, FDC blue no. 2, FDC yellow no.5, FDC yellow no.6, titanium dioxide, soybean, forsythia suspensa fruit, lonicera japonica flower, hypromellose 2910 (15000 mpa.s), glycyrrhiza uralensis, notopterygium incisum root, phragmites australis root, polydextrose, polyethylene glycol 4000, schizonepeta tenufolia spike

YINCHIAO, NDC58975-022-01, Acetaminophen - Pain Reliever-Fever Reducer, Chlorpheniramine Maleate - Antihistamine, See new warnings information, 120 Tablets
IMAGE OF CARTON
YINCHIAO 
acetaminophen and chlorpheniramine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58975-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN162.5 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PLATYCODON GRANDIFLORUM LEAF (UNII: 2L64H2X8DY)  
ARCTIUM LAPPA FRUIT (UNII: EA541308MV)  
MINT (UNII: FV98Z8GITP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SOYBEAN (UNII: L7HT8F1ZOD)  
FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
HYPROMELLOSE 2910 (15000 MPA.S) (UNII: 288VBX44JC)  
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)  
NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)  
PHRAGMITES AUSTRALIS ROOT (UNII: BBJ7AOM815)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SCHIZONEPETA TENUFOLIA SPIKE (UNII: 2FN3BA1MZE)  
Product Characteristics
Coloryellow (YC) Scoreno score
ShapeROUND (YC) Size10mm
FlavorImprint Code YC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58975-022-01120 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/16/2011
Labeler - TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY (654133313)

Revised: 2/2011
Document Id: 01043c5c-934e-4074-9540-156ef4324e24
Set id: f94ed467-b986-4ee2-b0df-f5f6d7e87a15
Version: 1
Effective Time: 20110216
 
TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY