NDC | 58975-022-01 |
Set ID | f94ed467-b986-4ee2-b0df-f5f6d7e87a15 |
Category | HUMAN OTC DRUG LABEL |
Packager | TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
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 - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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 - STORAGE AND HANDLING
- QUESTIONS
-
INACTIVE INGREDIENT
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 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
YINCHIAO
acetaminophen and chlorpheniramine maleate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58975-022 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 162.5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg Inactive Ingredients Ingredient Name Strength 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 Color yellow (YC) Score no score Shape ROUND (YC) Size 10mm Flavor Imprint Code YC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58975-022-01 120 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/16/2011 Labeler - TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY (654133313)