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Entex La Warnings, Precautions, Pregnancy, Nursing, Abuse - Guaifenesin and Phenylephrine
WARNINGS
Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.
PRECAUTIONS
Information for the Patient: Do not crush or chew phenylephrine HCl w/ guaifenesin long acting tablets prior to swallowing.
Drug/Laboratory Test Interactions: Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindole-acetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with phenylephrine HCl w/guaifenesin long acting tablets. It is also not known whether phenylephrine HCl w/guaifenesin long acting tablets, can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine HCl w/guaifenesin long acting tablets, should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether the drugs in phenylephrine HCl w/guaifenesin long acting tablets, are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the product, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of phenylephrine HCl w/guaifenesin long acting tablets, in children below the age of 6 have not been established.
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