BRONCOMAR EXPECTORANT SF- guaifenesin liquid

Broncomar Expectorant by

Drug Labeling and Warnings

Broncomar Expectorant by is a Otc medication manufactured, distributed, or labeled by Dannso Corp./d.b.a. Essential Products, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients:(in each 5 ml.): Purpose
• Guaifenesin 100 mg.......................................................:

  Expectorant

PURPOSE

Uses:

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.

WARNINGS

Warnings

Do not exceed recommended dosage

ASK DOCTOR

Ask doctor before use if you have

• Cough that occurs with too much phlegm(mucus)
• Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor before use

• Nervousness, dizziness or sleeplessness occurs.
• Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be sign serious condition.

Do not use

• If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

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. Avoid alcoholic beverages while using this product.

DOSAGE & ADMINISTRATION

Directions

• Do not exceed 6 doses in any 24 hour period.
• Shake well before use

• AGE: DOSE
• Adults and Children 12 years 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

INDICATIONS & USAGE

Other Information:

• Each 5 mls contains: sodium 8 mg
• Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
• Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

Blue Cohosh, Citric Acid, Echinacea Oil, Ginkgo Biloba, Glycerin Seal Root, Honey Flavor, Horehound Herb, Licorice, Golden Seal Root, Menthol, Mullein, Myrrh, Potassium Sobate, Slippery Elm Bark, Sodium Benzoate, Propylene Glycol, Purifed Water, sodium Chloride, Sucralose, Wild Cheery bark, and Zinc Sulfate.

Questions or Comments

Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762

Distributed by

Essential Products Miami FL 33126

www.jjjdistributors.com

Made in U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOMAR EXPECTORANT  SF
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70242-100
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
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ECHINACEA (UNII: 4N9P6CC1DX)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GINKGO (UNII: 19FUJ2C58T)
GLYCERIN (UNII: PDC6A3C0OX)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
HOREHOUND (UNII: K08036XEJV)
LICORICE (UNII: 61ZBX54883)
MENTHOL (UNII: L7T10EIP3A)
VERBASCUM THAPSUS (UNII: C9TD27U172)
MYRRH (UNII: JC71GJ1F3L)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70242-100-06	1 in 1 CARTON	01/01/2015
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2001

Labeler - Dannso Corp./d.b.a. Essential Products (059741071)

Registrant - Dannso Corp./d.b.a. Essential Products (059741071)

Establishment
Name	Address	ID/FEI	Business Operations
Dannso Corp./d.b.a. Essential Products		059741071	LABEL(70242-100)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(70242-100)