The following Structured Product Label (SPL) was submitted to the FDA by Talbot�s Pharmaceuticals Family Products, Llc. for the product Dr Talbots Infant Cough Relief (NDC 70797-319). 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 ingredients, ask a doctor, pregnancy, keep out of reach of children section, inactive ingredients, dosage, question, instructions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (HPUS)
Active Ingredient (30013v3 Dthf Infant Cough Box)
Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.
Please consult your physician immediately for a worsening condition
.
Active Ingredient (30013v3 Dthf Infant Cough Box)
Active Ingredient (30013v3 Dthf Infant Cough Box)
If pregnant or breastfeeding, consult your doctor before use.(SEE ATTCHED PRODUCT LABEL IMAGE)
Active Ingredient (30013v3 Dthf Infant Cough Box)
Keep out of reach of children. In case of overdoes (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.(SEE ATTCHED PRODUCT LABEL IMAGE)
Active Ingredient (30013v3 Dthf Infant Cough Box)
Active Ingredient (30013v3 Dthf Infant Cough Box)
For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.
Children 6 - 18 lbs or 3 - 8 kgs
1.25 ml every 2 hours, reduce frequency when symptoms improve
Children 19 - 29 lbs or 9 - 13 kgs
2.5 ml every 2 hours, reduce frequency when symptoms improve
Children 30 - 90 lbs or 14 - 41 kgs
5 ml every 2 hours, reduce frequency when symptoms improve
Active Ingredient (30013v3 Dthf Infant Cough Box)
Questions or Comments?(SEE ATTCHED PRODUCT LABEL IMAGE)
Active Ingredient (30013v3 Dthf Infant Cough Box)
Children
6 - 18 lbs
or 3 - 8 kgs
1.25 mL every 2 hours,
reduce frequency when
symptoms improve
Children
19 - 29 lbs
or 9 - 13 kgs
2.5 mL every 2 hours,
reduce frequency when
symptoms improve
Children
30 - 90 lbs
or 14 - 41 kgs
5 mL every 2 hours,
reduce frequency when
symptoms improve
Warnings
Do not use:
A persistent cough may be a sign of a serious condition
Active Ingredient (30013v3 Dthf Infant Cough Box)
Temporarily Relieves:
Active Ingredient (30013v3 Dthf Infant Cough Box)
Uses
Temporarily relieves
Active Ingredient (30013v3 Dthf Infant Cough Box)
Principal Display Panel
Active Ingredient (30013v3 Dthf Infant Cough Box)
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