FDA.reportPublic FDA data

Dr. Talbots Gas Colic Relief

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC
Effective date
2021-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:02

Label at a glance#

ProductDr. Talbots Gas Colic Relief
Active ingredientRADISH, POTASSIUM CHLORIDE, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, LYCOPODIUM CLAVATUM SPORE, FENNEL SEED, NUTMEG, GINGER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 sy...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Carbo Vegetabilis 12X HPUS
Chamomilla 12X HPUS
Foeniculum Vulgare 12X HPUS
Lycopodium 30X HPUS
Nux Moschata 12X HPUS
Raphanus Sativus 12X HPUS
Zingiber Officinale 12X HPUS

Cell Salts
Kali muriaticum 6X HPUS
Magnesia phosphorica 12X HPUS
Natrum phosphoricum 6X HPUS

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

Purpose

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

PurposePurpose

Pregnancy or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, consult your doctor before use.

PregnancyPregnancy

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Keep out of reach of childrenKeep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 INGREDIENT SECTION

Inactive ingredients

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

Inactive IngredientsInactive Ingredients

Questions

OTC - QUESTIONS SECTION

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

QuestionsQuestions

Uses

INDICATIONS & USAGE SECTION

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

07-20-202007-20-2020

Warnings

WARNINGS SECTION

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.

WarningWarning

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70797-310-01Dr. Talbots Gas Colic Relief1 in 1 CARTONLIQUID14
70797-310-04Dr. Talbots Gas Colic Relief118 mL in 1 BOTTLELIQUID1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-310DR. TALBOTS GAS COLIC RELIEF (CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC]4Current NDC, Legacy NDC, 2 package rows20211006_91213655-92d2-64c2-e053-2995a90aaa5a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-31070797-310-04, 70797-310-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
RADISHEM5RP35463ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
APPLE JUICE9871T0PD5PIACT
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
GLYCERINPDC6A3C0OXIACT
FENNEL SEEDG3QC02NIE6ACTIB
NUTMEGAEE24M3MQ9ACTIB
GINGERC5529G5JPQACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Talbots Gas Colic ReliefCARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUMTalbot's Pharmaceuticals Family Products, LLC91213655-92d2-64c2-e053-2995a90aaa5a2021-10-05WarningsExact identifier
ndc (package): 70797-310-01
ndc (package): 70797-310-04
ndc (product): 70797-310
ndc11 (package): 70797031004
ndc11 (package): 70797031001
spl id: cda11a45-6019-dbac-e053-2a95a90a2c1b
spl set id: 91213655-92d2-64c2-e053-2995a90aaa5a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.