Label: HANSHINNOCOL- acetaminophen, cholorpheniramine maleate, dextromethorphan hydrobromide capsule
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- NDC Code(s): 53153-102-01, 53153-102-04, 53153-102-05
- Packager: Han Kook Shin Yak Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 11, 2019
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- Acetaminophen 100 mg Chlorpheniramine maleate 1.25 mg Dextromethorphan Hydrobromide 7.5 mg
- Pain reliever/ fever reducer Antihistamine Cough suppressant
- Keep out of reach of children • In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Uses • temporarily relieves these symptoms due to a cold or flu • minor aches and pains • headache • nasal congestion • runny nose • cough • sneezing • sore throat • excessive phlegm • temporarily reduces fever
- Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 3 doses in 24 hours, which is the maximum daily amount • child takes more than 1 dose in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day while using this productSore throat warning 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. 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. • exceed recommended dosage and administration. • with the following medication: Antitussive expectorants, other cold medication, antipyretic and analgesics, antihistamine drugs, sedatives, etc. • for a long term • if your child is allergic to acetaminophen or any of the inactive ingredients in this product • if you have previously experienced sensitivity to this medication (e.g., rash, skin redness, itching of skin, swollen throat, eyes, lips and other parts) • if you had asthma after taking this medication or other antipyretic analgesics so far Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user have • liver disease • thyroid disease • diabetes • hypertension • weak constitution or high fever • heart disease or the elderly • kidney disease • glaucoma (e.g., eye pain or dimmed vision, etc.) • parents or siblings who are susceptible to urticaria, contact dermatitis, bronchial asthma, allergic rhinitis, migraines, food allergies, etc. • previously experienced drug allergies (e.g., fever, rash, joint pain, asthma, skin irritation, etc.) • varicella or influenza or infants and children under 14 years of age who are suspected of varicella or influenza • difficulty in urination • edema • undergoing therapy or dental treatment Ask a doctor or pharmacist before use (for children and infants) • Children should take this medication under the guidance of their parents. • Infants under 2 years old should be given treatment by a doctor and should not take this medication unless it is absolutely necessary; infants under 2 years old should take this medication with the guardian's awareness and should be monitored closely. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin When using this product • may cause drowsiness • avoid alcoholic drinks • avoid driving or operating machinery • may cause slight irritation to skin, eyes, and mucous membranes • together with preparations containing potassium, licorice components, glycyrrhizic acid (or its salt), or loop diuretics (e.g., furosemide and ethacrynic acid), or thiazide diuretics (e.g, trichlormethiazide), muscle disorders caused by pseudoaldosteronism and hypokalemia may readily occur. Please use it with caution. • please use it with caution, this product contains dye Yellow No. 5 (Sunset Yellow FCF). Individuals who are sensitive or have a history of allergy to this ingredient . Stop use and ask a doctor if • occurrence of reduced urine output, swelling of the face or limbs, heavy eyelids, stiffness of hands, high blood pressure or headache, and other symptoms after taking this product. • Pseudo aldosterone disease: When individuals are in long-term use of the preparation of which the daily dose of licorice is over 1g, symptoms of pseudoaldosteronism, such as hypokalemia, increased blood pressure, sodium and water retention, edema, and weight gain, may occur. After a full observaion (e.g., determination of serum potassium concentration), • Myopathy (muscle disorders): Hypokalemia may lead to muscle diseases. • fatigue, spastic quadriplegia, or paralysis are confirmed through a full observation. • rash, skin redness, nausea, vomiting, loss of appetite, difficulty in urination, vertigo, etc., occur • urticaria, swollen throat, eyelids, lips, and other parts, chest congestion accompanied by paleness, cold limbs, cold sweats, shortness of breath, etc. • scald-like blisters, etc., occurring on systemic skin, mouth and eye mucous membrane accompanied by high fever. • asthma • there is no remission of symptoms after several dosages If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.
- Directions • do not take more than the recommended dose • adults: take 2 capsules per session, 3 times per day, 30 minutes after meal. • children 7 to 14 years: take 1 capsule per session, 3 times per day, 30 minutes after meal. (under the guidance of parents.) • children 2 to 7 years: ask a doctor under the guidance of parents • under 1 year : do not use
- Pueraria lobata Root Extract, Glycyrrhiza glabra Extract, Cinnamomum cassia Extract, Paeonia lactiflora Extract, Zingiber officinale Extract, Jujube fruit Extract, Guaiacol Potassium Sulfonate, Caffeine Anhydride, Corn Starch, Lactose, Capsule
- HANSHINNOCOL CAPSULE
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INGREDIENTS AND APPEARANCE
HANSHINNOCOL
acetaminophen, cholorpheniramine maleate, dextromethorphan hydrobromide capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53153-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 100 mg in 500 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1.25 mg in 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg in 500 mg Inactive Ingredients Ingredient Name Strength PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CHINESE CINNAMON OIL (UNII: A4WO0626T5) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) GINGER (UNII: C5529G5JPQ) JUJUBE FRUIT (UNII: G55HNL2C70) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color brown Score no score Shape CAPSULE Size 20mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53153-102-05 1 in 1 BOX 06/30/2015 1 NDC:53153-102-04 10 in 1 BLISTER PACK 1 NDC:53153-102-01 500 mg in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/30/2015 Labeler - Han Kook Shin Yak Pharmaceutical Co., Ltd. (689277536) Registrant - Han Kook Shin Yak Pharmaceutical Co., Ltd. (689277536) Establishment Name Address ID/FEI Business Operations Han Kook Shin Yak Pharmaceutical Co., Ltd. 689277536 manufacture(53153-102)
