ROMPE PECHO DM- dextromethorphan hbr, guaifenesin liquid

Rompe Pecho by

Drug Labeling and Warnings

Rompe Pecho by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

Guaifenesin 100 mg ................................................................... Expectorant

PURPOSE

Purpose

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses:

• temporarily relieves cough as may occur with the common cold
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.

WARNINGS

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

• a cough that is accompanied by excessive phlegm (mucus)
• a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

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

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

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

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO  DM
dextromethorphan hbr, guaifenesin liquid

Product 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)