NDC | 58593-225-06 |
Set ID | bc10695a-9664-4ce3-82bb-820da06129fa |
Category | HUMAN OTC DRUG LABEL |
Packager | Efficient Laboratories Inc |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not exceed recommended dosage
Do not use • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.
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DO NOT USE
Ask a doctor before use if you have • heart disease • glaucoma • high blood pressure • thyroid disease • diabetes • difficulty in urination due to an enlarged prostate gland • a persistent or chronic cough such as occurs with smoking, asthma or emphysema • a cough that is accompanied by excessive phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives
or tranquilizers.When using this product • may cause drowsiness • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children.
Stop use and ask a doctor if • symptoms do not improve within 7 days, cough tends to recur, or symptoms are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. • if nervousness, dizziness, or sleeplessness occur - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- shake well before use
- do not exceed more than 6 doses in any 24-hour period or as directed by a doctor
Age Doseadults and children 12 years of age and over 5 mL (1 tsp) every 4 hours
children 6 to under 12 years of age 2.5 mL (1/2 tsp) every 4 hours
children under 6 years of age consult a doctor
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INACTIVE INGREDIENT
Inactive Ingredients:
Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerine, Golden Seal Root extract,
Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate,
Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract, Zinc Sulfate. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROMPE PECHO SF FLU
dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-225 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) GINKGO (UNII: 19FUJ2C58T) GOLDENSEAL (UNII: ZW3Z11D0JV) HONEY (UNII: Y9H1V576FH) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI) MYRRH (UNII: JC71GJ1F3L) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) ZINC SULFATE (UNII: 89DS0H96TB) HOREHOUND (UNII: K08036XEJV) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYGLYCERIN-10 (UNII: P9060O936A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-225-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2007 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932)