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  5. Label Information: Yinchiao

FDA Label for Yinchiao

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. OTC - QUESTIONS
    15. INACTIVE INGREDIENT
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Yinchiao Product Label

The following document was submitted to the FDA by the labeler of this product Tianjin Zhongxin Pharmaceutical Group Corp Ltd Longshunrong Pharmaceutical Factory. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - Purpose



Purpose
Pain reliever-fever reducer
Antihistamine


Indications & Usage



Usestemporarily relieves these symptoms due to a cold, the flu, or hay fever:minor aches and pains headachesore throatsneezingrunny noseitchy, watery eyesitching of the nose or throattemporarily reduces fever

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.


Otc - Do Not Use



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


Otc - Ask Doctor



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


Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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


Otc - 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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.


Dosage & Administration



Directionsadults 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 doctorchildren 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 doctorchildren under 6 years: consult a doctor of age

Storage And Handling



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


Otc - Questions



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 Ingredient



Inactive ingredientsScutellaria 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

Package Label.Principal Display Panel



YINCHIAO, NDC58975-022-01, Acetaminophen - Pain Reliever-Fever Reducer, Chlorpheniramine Maleate - Antihistamine, See new warnings information, 120 Tablets

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