FDA.reportPublic FDA data

Dr. Talbots Tummy Ache Relief

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC
Effective date
2021-10-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:02

Label at a glance#

ProductDr. Talbots Tummy Ache Relief
Active ingredientACTIVATED CHARCOAL, NUTMEG, POTASSIUM CHLORIDE, MATRICARIA CHAMOMILLA, CALENDULA OFFICINALIS FLOWERING TOP, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, LYCOPODIUM CLAVATUM SPORE, GINGER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FENNEL SEED
Label structure10 sections

Indications and uses

Uses Temporarily relieves infant discomfort caused by gas colic nausea stomach pressure and cramps diarrhea upset stomach nervous tummy indigestion minor stomach pain excessive stomach acid

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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Calendula officinalis 12X HPUS

Carbo Vegetabilis 12X HPUS
Chamomilla 12X HPUS
Foeniculum Vulgare 12X HPUS
Lycopodium 30X HPUS
Nux Moschata 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

Upset stomach

Nausea and vomiting

Abdominal pain associated with nervousness

Upset stomach

Gas, diarrhea
Indigestion
Stomach hyperacidity
Abdominal inflammation
Abdominal colic type 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

dosagedosage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

Inactive ingredientInactive ingredient

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
  • nausea
  • stomach pressure and cramps
  • diarrhea
  • upset stomach
  • nervous tummy
  • indigestion
  • minor stomach pain
  • excessive stomach acid

indicationsindications

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.

warningswarnings

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
70797-311-01Dr. Talbots Tummy Ache Relief1 in 1 CARTONLIQUID13
70797-311-04Dr. Talbots Tummy Ache Relief118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-311DR. TALBOTS TUMMY ACHE RELIEF (CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC]3Current NDC, Legacy NDC, 2 package rows20211006_91c1e0ae-9999-0ae2-e053-2995a90a2d71.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
70797-31170797-311-04, 70797-311-01

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
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
APPLE JUICE9871T0PD5PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
NUTMEGAEE24M3MQ9ACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
GINGERC5529G5JPQACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
FENNEL SEEDG3QC02NIE6ACTIB

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 Tummy Ache ReliefCALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUMTalbot's Pharmaceuticals Family Products, LLC91c1e0ae-9999-0ae2-e053-2995a90a2d712021-10-05WarningsExact identifier
ndc (package): 70797-311-04
ndc (package): 70797-311-01
ndc (product): 70797-311
ndc11 (package): 70797031101
ndc11 (package): 70797031104
spl id: cda11fa8-ab3d-bd89-e053-2a95a90a8c0e
spl set id: 91c1e0ae-9999-0ae2-e053-2995a90a2d71

Reported adverse events (FAERS/openFDA)#

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