Sinutab Cold/Sinutab Cold Plus Use In Pregnancy & Lactation

Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant or breastfeeding women for the combination of chlorpheniramine, paracetamol and phenylephrine.
Paracetamol: There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women for paracetamol. When given to the mother in labeled doses, paracetamol crosses the placenta into fetal circulation as early as 30 minutes after ingestion and is effectively metabolized by fetal sulfate conjugation. When taken as directed, paracetamol does not adversely affect the pregnant mother or fetus.
Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal ingestion of paracetamol in labeled doses does not present a risk to the nursing infant.
Phenylephrine: There are no adequate and well-controlled studies in pregnant or breast-feeding women. It is not known if phenylephrine or its metabolites are excreted in human milk.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus or breastfeeding infant. Ask a physician before use if the patient is pregnant or breastfeeding.
Sinutab Cold Plus: Chlorpheniramine: There are no adequate or well-controlled studies of chlorpheniramine in pregnant or breastfeeding women. It is not known whether chlorpheniramine or its metabolites are excreted in breast milk.