A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Organidin Indications, Dosage, Storage, Stability - Guaifenesin (oral)
Organidin Indications, Dosage, Storage, Stability - Guaifenesin (oral)
INDICATIONS
ORGANIDIN® NR* (* Newly Reformulated): Helps loosen
phlegm (mucus) and thin bronchial
secretions to rid the bronchial
passageways of bothersome mucus,
drain bronchial
tubes and make coughs more productive. Helps loosen phlegm
and thin bronchial
secretions in patients with stable chronic bronchitis.
TUSSI-ORGANIDIN® NR* (* Newly Reformulated) and TUSSI-ORGANIDIN®
DM NR* (* Newly Reformulated): Temporarily relieves cough
due to minor throat and bronchial
irritation as may
occur with the common cold
or inhaled irritants. Calms the cough
control center
and relieves coughing.
DOSAGE AND ADMINISTRATION
ORGANIDIN® NR* (* Newly Reformulated) (guaifenesin)
Tablets — Adults and children 12 years of age
and older: One to 2 tablets (200 mg
to 400 mg) every four hours, not to exceed 2400 mg (12 tablets)
in 24 hours.
Extended release tablet (Mucinex) - 600-1200 mg every 12 hours, not to exceed 2.4 grams/day
Liquid — Adults and children 12 years of age
and older: Two to four teaspoonfuls (200 mg
to 400 mg) every four hours, not to exceed 2400 mg
(24 teaspoonfuls) in 24 hours.
Children 6 years to under 12 years of age: One to
two teaspoonfuls (100 mg
to 200 mg) every four hours, not to exceed 1200 mg (12 teaspoonfuls)
in 24 hours.
Children 2 years to under 6 years of age: 1/2 to
1 teaspoonful (50 mg to 100
mg) every four hours, not to exceed 600 mg
(6 teaspoonfuls) in 24 hours.
Children 6 mo. to under 2 years of age: A common
dosage is 1/4 to 1/2 teaspoonful (25 mg
to 50 mg) every four hours, not to exceed 300 mg
(3 teaspoonfuls) in 24 hours. Individualized dosage
should be determined by evaluation
of patient.
TUSSI-ORGANIDIN® NR* (* Newly Reformulated) Liquid
Adults and children 12 years of age
and older: 2 teaspoonfuls (10 mL) every four hours, not
to exceed 12 teaspoonfuls (60 mL) in 24 hours.
Children 6 years to under 12 years of age: 1 teaspoonful
(5 mL) every four hours, not to exceed 6 teaspoonfuls (30 mL) in
a 24 hour period.
Children 2 to under 6 years of age: Oral dosage
is based on 1 mg/kg/day of codeine
administered in four equal divided doses. The average body
weight for each age
group may also be used
to determine codeine dosage as follows:
For children 2 years of age
(average body weight
12 kg): The oral dosage
is 1.5 mL (3 mg codeine
+ 30 mg guaifenesin) TUSSI-
ORGANIDIN® NR* (* Newly Reformulated) Liquid every 4-6 hr, not
to exceed 6 mL (12 mg codeine
+ 120 mg guaifenesin) in
a 24 hr period.
For children 3 years of age
(average 14 kg): 1.75 mL (3.5 mg codeine + 35 mg
guaifenesin) every 4-6 hours, not to exceed 7 mL (14 mg codeine
+ 140 mg guaifenesin) in
24 hours.
For children 4 years of age
(average 16 kg): 2 mL (4 mg
codeine + 40 mg guaifenesin)
every 4-6 hours, not to exceed 8 mL (16 mg
codeine + 160 mg guaifenesin)
in 24 hours.
For children 5 years of age
(average 18 kg): 2.25 mL (4.5 mg codeine + 45 mg
guaifenesin) every 4-6 hours, not to exceed 9 mL (18 mg codeine
+ 180 mg guaifenesin) in
24 hours.
Patients should be instructed to obtain and use a dispensing device
(such as a dropper calibrated
for age or weight) to administer
the drug to a child, to use extreme care in measuring dosage,
and not to exceed the recommended daily dosage.
CODEINE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 2 YEARS OF
AGE. Children under 2 years of age
may be more susceptible
to the respiratory depressant effects of codeine, including respiratory
arrest, coma and death.
TUSSI-ORGANIDIN® DM
NR* (* Newly Reformulated) Liquid
Adults and children 12 years of age
and older: 2 teaspoonfuls (10 mL) every four hours not to
exceed 12 teaspoonfuls (60 mL) in 24 hours.
Children 6 years to under 12 years of age: 1 teaspoonful
(5 mL) every four hours not to exceed 6 teaspoonfuls (30 mL) in
24 hours.
Children 2 to under 6 years of age: 1/2 teaspoonful
(2.5 mL) every four hours not to exceed 3 teaspoonfuls (15 mL) in
24 hours.
Children 6 mo. to under 2 years of age: A common
dosage is 1/8 teaspoonful to 1/4 teaspoonful (0.6 mL to 1.25 mL)
every 4 hours or 1/2 teaspoonful (2.5 mL) every 6-8 hours, not to
exceed 1.5 teaspoonfuls (7.5 mL) in 24 hours. Individualized dosage
should be determined by evaluation of patient.
PATIENTS SHOULD BE ADVISED TO
KEEP THESE AND ALL DRUGS
OUT OF THE REACH OF CHILDREN AND TO
S.E. PROFESSIONAL ASSISTANCE
OR CONTACT A POISON CONTROL
CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.
HOW SUPPLIED
ORGANIDIN® NR* (* Newly Reformulated) (guaifenesin)
Tablets — Each round, scored, rose-colored tablet
contains 200 mg guaifenesin
USP— available in bottles of 100 (NDC 0037-4312-01)
Extended-Release Tablets: (Mucinex) - 600 mg
Liquid — 100 mg
guaifenesin per
teaspoonful (5 mL) — available as a clear amber liquid
in bottles of 1 pint (NDC
0037-4214-10) and 1 gallon (NDC 0037-4214-20)
TUSSI-ORGANIDIN® NR* (* Newly Reformulated)
Liquid — Guaifenesin 100 mg
and codeine phosphate
10 mg per teaspoonful (5 mL) of clear red
liquid in bottles of
one pint (NDC 0037-4814-10),
one gallon (NDC 0037-4814-20),
and 4 fl o (NDC 0037-4814-01)
labeled TUSSI-ORGANIDIN®-StNR*, TUSSI-ORGANIDIN®-SNR* and
TUSSI-ORGANIDIN® NR*.
TUSSI-ORGANIDIN® DM
NR* (* Newly Reformulated)
Liquid — Guaifenesin 100 mg
and dextromethorphan
hydrobromide 10 mg per
teaspoonful (5 mL) of clear yellow
liquid in bottles of
one pint (NDC 0037-4714-10), one gallon
(NDC 0037-4714-20), and 4 fl oz
(NDC 0037-4714-01) labeled TUSSI-ORGANIDIN® DM-StNR*, TUSSI-ORGANIDIN®
DM-SNR* and TUSSI-ORGANIDIN® DM
NR* Liquids, respectively, either in 4 fl oz
unit of use containers with a 10 mL graduated
oral syringe
and fitment or in 30 mL sample
containers.
STORAGE — Store at controlled room
temperature 15°-
30° C( 59°- 86° F). Protect from light. Keep bottle
tightly closed.
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