NDC | 76117-001-16 |
Set ID | c91798fa-48ab-47a0-92da-4d44c2aafde0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Okendpharma, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Chlorpheniramine Maleate 2mg............................................................Antihistamine
Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant - PURPOSE
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WARNINGS
Warnings Do not use - To sedate a child or to make a child sleepy. - If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
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ASK DOCTOR
Ask a doctor before use if you have - Heart disease. - Thyroid disease. - Trouble urinating due to enlarged prostate gland. - Glaucoma. - Cough that occurs with too much phlegm (mucus). - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- ASK DOCTOR/PHARMACIST
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WHEN USING
When using this product - Do not use more than directed. - May cause marked drowsiness. - Avoid alcoholic beverages. - Alcohol, sedatives and tranquilizers may cause increased drowsiness. - Be careful when driving a motor vehicle or operating machinery. - Excitability may occur, especially with children.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RYCONTUSS CHERRY FLAVOR
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76117-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76117-001-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/31/2011 Labeler - Okendpharma, Inc. (832814276) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc. 007392322 manufacture(76117-001)