Lufyllin -GG (Page 2 of 2)

Dosage and Administration

Dosage should be individually titrated according to the severity of the condition and the response of the patient.

Usual adult dosage:
30 mL (two tablespoonfuls) oral solution, four times daily.

Children above age six:
15 to 30 mL (one to two tablespoonfuls) oral solution, three or four times daily.

Not recommended for use in children below age six: (see Precautions).

How Supplied

LUFYLLIN®-GG Oral Solution (dyphylline 100 mg, guaifenesin 100 mg and alcohol 17% by volume per 15 mL) is a clear, light yellow-orange liquid with a mild wine-like odor and taste. The oral solution is available in bottles of one pint (NDC 0037-0545-68).

Storage:

Store at controlled room temperature 20°-25°C (68°-77°F).

Dispense in a tight container.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

MEDA Pharmaceuticals
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

Printed in U.S.A. Rev. 1.09

Package Label — Principal Display Panel – One Pint Bottle, Lufyllin-GG Oral Solution

NDC 0037-0545-68
One Pint (473 mL)
Lufyllin®-GG
(dyphylline and
guaifenesin oral
solution, USP)
Oral Solution
Each 15 mL (one tablespoonful)
contains:
Dyphylline 100 mg
Guaifenesin 100 mg
Alcohol (by volume) 17%
Rx Only
MEDA
Pharmaceuticals
LB-054502-09 Rev. 8/07
Usual Dosage: See package insert.
Store at controlled room temperature 20°-25°C
(68°-77°F).
Dispense in a tight container.
MEDA Pharmaceuticals
Meda Pharmaceuticals Inc.Somerset, New Jersey 08873-4120

Lufyllin-GG Oral Solution -- One Pint Bottle Label
(click image for full-size original)
LUFYLLIN -GG dyphylline and guaifenesin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-0545
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DYPHYLLINE (DYPHYLLINE) DYPHYLLINE 100 mg in 15 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW (light yellow-orange) Score
Shape Size
Flavor GRAPE (wine like flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0037-0545-68 473 mL in 1 BOTTLE None
2 NDC:0037-0545-74 30 mL in 1 BOTTLE None
3 NDC:0037-0545-69 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/01/1968 03/31/2013
Labeler — Meda Pharmaceuticals Inc. (051229602)

Revised: 07/2011 Meda Pharmaceuticals Inc.

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