Dr. Talbots Gas Colic Relief Liquid
FDA Label NDC 70797-310

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Talbot's Pharmaceuticals Family Products, Llc for the product Dr. Talbots Gas Colic Relief (NDC 70797-310). 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, purpose, pregnancy or breastfeeding, keep out of reach of children, directions, inactive ingredients, questions, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Pregnancy Or Breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions

→ Uses

→ Warnings

→ Principal Display Panel

Active Ingredients

Carbo Vegetabilis 12X HPUS
Chamomilla 6X HPUS
Cinchona Officinalis 6X HPUS
Colocynthis 12X HPUS
Foeniculum Vulgare 6X HPUS
Lycopodium 30X HPUS
Nux Moschata 6X HPUS
Raphanus Sativus 6X HPUS
Zingiber Officinale (Ginger) 6X HPUS

Cell Salts
Kali muriaticum 6X HPUS
Magnesia phosphorica 6X HPUS
Natrum phosphoricum 6X HPUS

Purpose

Abdominal pain due to excessive gas
Abdominal discomfort with associated irritability
Abdominal pressure due to excessive gas, diarrhea
Colic type abdominal pain
Indigestion
Excessive gas
Nausea, diarrhea
Abdominal distension
Stomach hyperacidity
Abdominal inflammation
Colic type abdominal pain
Stomach hyperacidity

Pregnancy Or Breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep Out Of Reach Of Children

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.

Directions

Shake before use, natural juice may settle
Measure only with the dosing syringe provided
Do not use dosing syringe with other products
On dosing syringe, weight is specific to product
On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

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, 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

Inactive Ingredients

Inactive ingredients

Apple juice, citric acid, glycerin, potassium sorbate, purified water

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Uses

Temporarily relieves infant discomfort caused by

gas
colic
groaning
crying
bloating
nausea
indigestion
restlessness
constipation
stomach discomfort and pressure
sleeplessness
fussiness
burping
excessive stomach acid
diarrhea

Warnings

Stop use and ask doctor if:

fever develops
diarrhea lasts more than 2 days
other symptoms persist for more than 7 days or worsen
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.

* Please review the disclaimer below.

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