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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Guaifenesin (oral)
Organidin Warnings, Precautions, Pregnancy, Nursing, Abuse - Guaifenesin (oral)
WARNINGS
Not for persistent cough such as occurs with smoking,asthma, chronic bronchitis, or emphysema or cough accompanied by excessive secretions. When used for self medication(OTC), contact healthcare provider if needed for more than 7 days or for cough with a fever, rash, or persistent headache.
PRECAUTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies to assess the long-term carcinogenic
and mutagenic potential or the effect
on fertility in animals
or humans have not been performed.
Pregnancy
Teratogenic Effects: Pregnancy Category C:
Animal reproduction studies have not been conducted. Safe use in
pregnancy has not
been established relative to possible adverse effects on fetal
development. Therefore, these products should not be used in pregnant
patients unless, in the judgment
of the physician,
the potential benefits
outweigh possible hazards.
Nursing Mothers
It is not known whether guaifenesin
or dextromethorphan
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when these products are administered
to a nursing woman
and a decision should be made whether to discontinue nursing
or to discontinue the drug,
taking into account the importance of the drug
to the mother.
TUSSI-ORGANIDIN® NR* (* Newly Reformulated): Because
the hepatic enzyme system,
which acts to conjugate
codeine to an inactive
glucuronide (an important inactivation
pathway), is not fully developed in infants less than 6 months of
age, the use of codeine
is contraindicated in nursing mothers.
Laboratory Test Interactions
Guaifenesin or its metabolites may cause
color interference
with the VMA (vanillylmandelic acid) test
for catechols. It may also falsely elevate the level of urinary
5-HIAA (5-hydroxyindoleacetic
acid) in certain serotonin metabolite chemical
tests because of color
interference.
Information for Patients See PATIENT
INFORMATION section.
Drug Interactions See DRUG
INTERACTIONS section.
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