NDC | 58593-275-04, 58593-275-06, 58593-275-08, 58593-275-10 |
Set ID | d108c712-bc36-41d7-9ccd-720496b5599e |
Category | HUMAN OTC DRUG LABEL |
Packager | Efficient Laboratories Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
DO NOT USE
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 on MAOI, ask a doctor or pharmacist before taking this product.
- Stop use and ask a doctor
- If cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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 Do not use
-
INACTIVE INGREDIENT
Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROMPE PECHO DM
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-275 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 Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) PROPOLIS WAX (UNII: 6Y8XYV2NOF) 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) ASCLEPIAS TUBEROSA ROOT (UNII: 1ZL82U5D18) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) SPEARMINT (UNII: J7I2T6IV1N) PRUNUS SEROTINA BARK (UNII: 5D48E975HA) ZINC SULFATE (UNII: 89DS0H96TB) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-275-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2001 2 NDC:58593-275-10 10 mL in 1 POUCH; Type 0: Not a Combination Product 10/01/2001 3 NDC:58593-275-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 4 NDC:58593-275-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2001 Labeler - Efficient Laboratories Inc (969044932) Registrant - Efficient Laboratories Inc (969044932)