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Rx Only
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
So. El Monte, CA 91733, U.S.A.
Amphastar Pharmaceuticals Company
Rev.7-00
6913900J
DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed.
Pregnancy
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose an have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
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OVERDOSAGE
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in pediatric patients. Atropine-like signs and symptoms, dry mouth; fixed, dilated pupils; flushing and gastrointestinal symptoms may also occur.
Stimulants should not be used.
Vasopressors may be used to treat hypotension.
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CONTRAINDICATIONS
Use in Neonates or Premature infants
This drug should not be used in neonates or premature infants.
Use in Nursing Mothers
Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
Use as a Local Anesthetic
Because of the risk of local necrosis, this drug should not be used as a local anesthetic.
Antihistamines are also contraindicated in the following conditions
Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.
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