PALATOS EXPECTORANTE- guaifenesin liquid

Palatos Expectorante by

Drug Labeling and Warnings

Palatos Expectorante by is a Otc medication manufactured, distributed, or labeled by All Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acvtive ingredients: (in each 5ml)              Purpose

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

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

Do not exceed recommended dosage

DO NOT USE

Do not use

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

Ask the doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

STOP USE

Stop use and ask the doctor if

• Nervoisness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be 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

• Do not take more than 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 tsps) every 4 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT

Inactive ingredients

Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, glycerin, gold seal root, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

Palatos

INGREDIENTS AND APPEARANCE

PALATOS EXPECTORANTE 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53149-2000
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)
GINKGO BILOBA WHOLE (UNII: 660486U6OI)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HOREHOUND (UNII: K08036XEJV)
LICORICE (UNII: 61ZBX54883)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)
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, UNSPECIFIED FORM (UNII: 89DS0H96TB)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53149-2000-6	1 in 1 BOX	01/01/2019
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	01/01/2019

Labeler - All Pharma, LLC (078572520)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma, LLC		078572520	MANUFACTURE(53149-2000)