Data from FDA - Curated by EPG Health - Last updated 18 December 2019

Indication(s)

INDICATIONS AND USAGE Se-Natal 19 Chewable Tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 Chewable Tablets are also useful in improving the nutritional status of women prior to conception.

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Advisory information

contraindications
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Special warnings and precautions
PRECAUTIONS GENERAL Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. ​Folic Acid Folic acid in doses above 0.1 mg daily may obscure pernicious anemia. In that hematologic remission can occur while neurological manifestations remain progressive. ​Pediatric Use Safety and effectiveness in pediatric patients have not been established. ​Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
Adverse reactions
​ADVERSE REACTIONS Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION One tablet daily, or as directed by a physician.

Interactions

DRUG INTERACTIONS Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

More information

Category Value
Agency product number 25X51I8RD4
Orphan designation No
Product NDC 13925-117
Date Last Revised 07-01-2019
Type HUMAN PRESCRIPTION DRUG
List of excipients ​OTHER INGREDIENTS Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.
Storage and handling STORAGE Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)[See USP controlled room temperature].
Marketing authorisation holder Seton Pharmaceuticals
Warnings WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.