ROMPE PECHO SF- guaifenesin liquid

Rompe Pecho by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (In each 5ml teaspoonful)................. Purpose

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

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Uses

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 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 accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
In case of accidental overdose, get medical help or contact the Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions:Shake well before use. Do not exceed 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 (2tsps) 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

INACTIVE INGREDIENT

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, 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

Questions or Comments?

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

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO   SF
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-265
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINKGO (UNII: 19FUJ2C58T)
GLYCERIN (UNII: PDC6A3C0OX)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HOREHOUND (UNII: K08036XEJV)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)
MYRRH (UNII: JC71GJ1F3L)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC SULFATE (UNII: 89DS0H96TB)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY (Honey Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-265-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
2	NDC: 58593-265-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/1999

Labeler - Efficient Laboratories, Inc. (969044932)