ROMPE PECHO EX- guaifenesin liquid

Rompe Pecho by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.

WARNINGS

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

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

DO NOT USE

Stop use and ask a doctor if

• cough persists for 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 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 and over       10 mL (2tsps) every 4 hrs.

children 6 to under 12 years of age            5 mL (1 tsp) every 4 hrs

children under 6 years of age                consult a doctor

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

Questions or Comments?

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

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO  EX
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-829
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 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)
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)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)
HOREHOUND (UNII: K08036XEJV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-829-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
2	NDC: 58593-829-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2015

Labeler - Efficient Laboratories Inc (969044932)