NDC | 58593-235-04, 58593-235-06, 58593-235-08, 58593-235-29 |
Set ID | 96c4dee1-6e66-4442-a7e3-56e874414c17 |
Category | HUMAN OTC DRUG LABEL |
Packager | Efficient Laboratories Inc |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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ACTIVE INGREDIENT
Active Ingredients:(in each teaspoonful 5 ml.) Purpose
Dextromethorphan HBr 10 mg ...................................... Cough Suppressant
Guaifenesin 100 mg ................................................................... Expectorant
Phenylephrine HCL 5 mg .................................................... Nasal Decongestant
- PURPOSE
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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 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
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DO NOT USE
Ask a doctor before use if you have
• heart disease• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• a persistant or chronic cough
- a cough that is accompanied by excessive phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask doctor if- symptoms do not improve within 7 days or is 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
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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 Dose adults and children 12 years of age and over
10 mL (2 tsps) every 4 hours children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours children under 6 years of age consult a doctor - INDICATIONS & USAGE
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INACTIVE INGREDIENT
Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROMPE PECHO CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-235 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) HOREHOUND (UNII: K08036XEJV) 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 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-235-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2007 2 NDC:58593-235-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 3 NDC:58593-235-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 4 NDC:58593-235-29 296 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 01/01/2015 5 NDC:58593-235-10 10 mL in 1 POUCH; Type 0: Not a Combination Product 01/01/2019 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)