The following Structured Product Label (SPL) was submitted to the FDA by Talbot's Pharmaceuticals Family Products,llc. for the product Dr Talbots Infant Tummy Ache Relief (NDC 70797-317). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, ask a doctor, pregnant, keep out of reach of children, inactive ingredient, dosage, questions, instruction, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (HPUS):
Cell Salts:
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
If pregnant or breastfeeding, consult your doctor before use.
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Keep out of reach
of children. In case of overdose (or accidental ingestion), get medical help or contact a Poison Control Center right away.
DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Inactive ingredients: Apple juice, citric acid, glycerin, potassium sorbate, purified water
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Children under 6 months of age,consult a medical professional before using this product.
For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, every 2 hours thereafter.
Children Dose
6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*
19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*
30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*
*Reduce frequency when symptoms improve.
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Questions or comments? Call us at 1-855-366-7755 (U.S.A. only) M-F 8am-5pm CST
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Children under 6 months of age, consult a medical professional before using this product.
For sudden onset of symptoms: Use every 15
minutes for up to 8 doses until symptoms relieved,
every 2 hours thereafter
Children Dose
6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours
19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours
30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours
*Reduce frequency when symptoms improve.
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Warnings:
Stop use and ask doctor if:
Temporarily relieves:
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Uses: Temporarily relieves infant discomfort caused by
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
Label Display Panel
Active Ingredient (30009v3 Dthf Infant Tummyache Label)
* Please review the disclaimer below.
