GREEN TUSSIN PEDIATRIC- guaifenesin, dextromethorphan hbr liquid

Green Tussin by

Drug Labeling and Warnings

Green Tussin by is a Otc medication manufactured, distributed, or labeled by Green Choice for Life Pediatric, Green Choice for Life, All Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 15 mL)

Dextromethorphan HBr 10mg.............Cough Suppressant

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

PURPOSE

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial sections to make coughs more productive.

Warnings

Do not exceed recommended dosage.

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

DO NOT USE

Do not use

• On child 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 child's prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.

Ask Doctor

• Before use for a persistent or chronic cough, such as occurs with asthma, chronic bronchitis or if cough is accompanied by excessive phlegm (mucus)

Stop Use

• if cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache. A persisten coug may be a sign of a serious condition.

PREGNANCY OR BREAST FEEDING

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

• Do not exceed 6 doses in 24 hours

children 6 to under 12 Years of age or more.............15mL ((3 tsp) every 4 hours

children 2 to under 6 Years of age or more.............7.5mL ((1 1/2 tsp) every 4 hours

children under 2 years of age..............................ask a doctor

OTHER SAFETY INFORMATION

Other information

• store this product between 15­­° to 30°C (59° to 86°F)
• Contains 0.1% of alcohol

INACTIVE INGREDIENT

Inactive Ingredients aloe, ascorbic acid, caramel color, cat's claw extract, corn syrup, ethyl alcohol, eucalyptus oil, garlic FE, ginger root FE, honey, menthol, methyl paraben, onion FE, peppermint spirits, potassium sorbate, propylene glycol, propyl paraben, sodium benzoate, sucralose

QUESTIONS

Questions? call 305-763-3228 M-F 9 am to 5 pm Eastern

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GREEN TUSSIN  PEDIATRIC
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55287-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	Guaifenesin	100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALOE (UNII: V5VD430YW9)
GINGER (UNII: C5529G5JPQ)
CAT'S CLAW (UNII: 9060PRM18Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT (UNII: V95R5KMY2B)
MENTHOL (UNII: L7T10EIP3A)
ONION (UNII: 492225Q21H)
GARLIC (UNII: V1V998DC17)
SUCRALOSE (UNII: 96K6UQ3ZD4)
CARAMEL (UNII: T9D99G2B1R)
HONEY (UNII: Y9H1V576FH)
CORN SYRUP (UNII: 9G5L16BK6N)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55287-112-06	1 in 1 CARTON	01/02/2021
1		180 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	02/21/2012

Labeler - Green Choice for Life Pediatric (828750526)

Registrant - Green Choice for Life (828750526)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma LLC		117605075	MANUFACTURE(55287-112)