Label: ROMPE PECHO SF FLU SF FLU- brompheniramine maleate, dextromethorphan hbr liquid
- NDC Code(s): 58593-002-06
- Packager: Efficient Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 7, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
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 your prescription drug contains an MAOI; ask your doctor or pharmacist before taking this product.
- If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or
-
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
Stop use and ask 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 sign of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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=miliiter 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 teaspoonfuls) every 4 hours
- children under 6 years of age
- do not use
- INDICATIONS & USAGE
-
INACTIVE INGREDIENT
Inactive Ingredients:Blue Cohosh root extract, citric acid, Echinacea root extract, Eucalyptus Oil, Flavor, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, 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.
- QUESTIONS
- Ask a doctor or pharmacist before use if you are:
- When using this product
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROMPE PECHO SF FLU SF FLU
brompheniramine maleate, dextromethorphan hbr liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-002 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 4 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW) EUCALYPTUS OIL (UNII: 2R04ONI662) CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) GLYCERIN (UNII: PDC6A3C0OX) ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH) GOLDENSEAL (UNII: ZW3Z11D0JV) HONEY (UNII: Y9H1V576FH) HOREHOUND (UNII: K08036XEJV) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) LICORICE (UNII: 61ZBX54883) MULLEIN LEAF (UNII: 9936O846LI) 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) MYRRH (UNII: JC71GJ1F3L) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-002-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2023 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932)