Label: ROMPE PECHO SF FLU- dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid
- NDC Code(s): 58593-225-06
- Packager: Efficient Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not exceed recommended dosage
Do not use• If you are now 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 your prescription drug contains an 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 • glaucoma • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the 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.
- STOP USE
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- do not exceed more than 6 doses in any 24-hour period
- shake well before use
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- TSP = teaspoonful
- this adult product is not intended for use in children under 12 years of age
Age Dose adults and children 12 years of age and over 5 mL (1 teaspoonful) every 4 hours children under 12 years of age do not use -
INACTIVE INGREDIENT
Inactive Ingredients:
Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, flavor, Ginkgo Biloba leaf extract, Glycerin, Goldenseal Root extract, Horehound (flower, leaf, stem) extract, 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 and Zinc Sulfate.
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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 Drug M012 10/01/2007 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932)