FDA.reportPublic FDA data

Dr Talbots Infant Daily Allergy Relief

Manufacturer
Talbot's Pharmaceuticals Family Products,LLC.
Effective date
2022-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:18:15

Label at a glance#

ProductDr Talbots Infant Daily Allergy Relief
Active ingredientARALIA RACEMOSA ROOT, EUPHRASIA STRICTA, LUFFA OPERCULATA FRUIT, ONION, ANEMONE PULSATILLA, HISTAMINE DIHYDROCHLORIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, SODIUM CHLORIDE
Label structure11 sections

Indications and uses

Temporrarily relieves the symptoms asscociated with hay fever or other upper respiratory allergies, such as itchy nose and throat watery eyes runny nose sneezing sinus pain mild wheezing

Dosage and administration

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 kg 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTSACTIVE INGREDIENTSActive ingredients (HPUS)

Allium cepa 12X
Aralia racemosa 12X
Euphrasia officinalis 12X.
Galphimia glauca 12X
Histaminum hydrochloricum 12X
Luffa operculata 12X
Pulsatilla 12X
Solidago 12X

CELL SALTS

Natrum muriaticum 6X

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTSINACTIVE INGREDIENTSInactive ingredients
Citric acid, glycerin, grape juice, potassium
sorbate, purified water

PURPOSE

OTC - PURPOSE SECTION

Temporarily Relieves:

  • Hay Fever
  • Sneezing
  • Mild wheezing
  • Itchy Nose, Thorat, & Watery Eyes
  • Runny & Stuffy Nose PurposePurpose

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

PREGNANCYPREGNANCYIf pregnant or breastfeeding, consult your doctor before use.
Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DOSAGEDOSAGEFor 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 kg

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

QUESTIONS

OTC - QUESTIONS SECTION

QUESTIONSQUESTIONSQuestions or comments?
Call us at 1-855-366-7755 (U.S.A. only)
M-F 8am-5pm CST

ASK A DOCTOR

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Please consult your physician immidiately for a worsening condition. Ask a DoctorAsk a Doctor

Warnings

WARNINGS SECTION

Warnings:

Do not use:

  • to treat food allergies
  • for persistent or chronic cough
  • for treating cough from asthma, smoking, or emphysema
  • for treating cough with excessive mucus

A persistent cough may be a sign of a serious condition.WarningsWarnings

Uses

INDICATIONS & USAGE SECTION

Temporrarily relieves the symptoms asscociated with hay fever or other upper respiratory allergies, such as

  • itchy nose and throat
  • watery eyes
  • runny nose
  • sneezing
  • sinus pain
  • mild wheezing UsesUses

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.Keep Out of Reach of ChildrenKeep Out of Reach of Children

PRINCIPAL DISPLAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PRINCIPAL DISPLAYPRINCIPAL DISPLAY

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
70797-322-01Dr Talbots Infant Daily Allergy Relief1 in 1 CARTONLIQUID11
70797-322-01Dr Talbots Infant Daily Allergy Relief118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-322DR TALBOTS INFANT DAILY ALLERGY RELIEF (ALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6X) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS,LLC.]1Current NDC, Legacy NDC, 2 package rows20221006_e8bdcc8a-c947-ff5d-e053-2a95a90a3b92.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70797-32270797-322-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ARALIA RACEMOSA ROOTT90W4582DUACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
WATER059QF0KO0RIACT
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
ONION492225Q21HACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
CONCORD GRAPE JUICEF7039Q79LPIACT
SODIUM CHLORIDE451W47IQ8XACTIB

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 Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
ndc (package): 70797-322-01
ndc (product): 70797-322
ndc11 (package): 70797032201
spl id: e8bdcc8a-c948-ff5d-e053-2a95a90a3b92
spl set id: e8bdcc8a-c947-ff5d-e053-2a95a90a3b92

Reported adverse events (FAERS/openFDA)#

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