FDA.reportPublic FDA data

Dr. Talbots Infant Daily Allergy Relief

Manufacturer
Talbot's Pharmaceuticals Family Products, LLC
Effective date
2021-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:34

Label at a glance#

ProductDr. Talbots Infant Daily Allergy Relief
Active ingredientLUFFA OPERCULATA FRUIT, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, ARALIA RACEMOSA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, SODIUM CHLORIDE, ONION, ANEMONE PULSATILLA, HISTAMINE DIHYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Allium cepa 12X HPUS

Aralia racemosa 12X HPUS

Euphrasia officinalis 12X HPUS

Galphimia glauca 12X HPUS

Histaminum hydrochloricum 12X HPUS

Luffa operaculata 12X HPUS

Pulsatilla 12X HPUS

Solidago 12X HPUS

Cell Salts

Natrum muriaticum 6X HPUS

Active ingredientsActive ingredients

OTC - PURPOSE SECTION

Purpose

Hay fever, watery eyes

Watery irritating nasal discharge

Eye irritation, watery eyes

Sneezing, runny nose

Hay fever, mild wheezing

Acute rhinitis

Sinus pain

Nasal discharge

Sneezing, itchy eyes

PurposePurpose

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, consult your doctor before use.

PregnancyPregnancy

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

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

DirectionsDirections

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Inactive ingredientsInactive ingredients

OTC - QUESTIONS SECTION

Questions or Comments?

Call us at 1-855-366-7755 (U.S.A only)

M-F 8am-5pm CST

QuestionsQuestions

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves the symptoms associated with hay fever or other upper respiratory allergies, such as

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

UsesUses

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

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
70797-308-01Dr. Talbots Infant Daily Allergy Relief1 in 1 CARTONLIQUID11
70797-308-04Dr. Talbots Infant Daily Allergy Relief118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70797-308DR. TALBOTS INFANT DAILY ALLERGY RELIEF (ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM) LIQUID [TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC]1Current NDC, Legacy NDC, 2 package rows20210601_c0963200-67dd-6349-e053-2a95a90adde1.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
70797-30870797-308-04, 70797-308-01

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
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
CONCORD GRAPE JUICEF7039Q79LPIACT
WATER059QF0KO0RIACT
ARALIA RACEMOSA ROOTT90W4582DUACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
ONION492225Q21HACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB

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, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUMTalbot's Pharmaceuticals Family Products, LLCc0963200-67dd-6349-e053-2a95a90adde12021-04-22WarningsExact identifier
ndc (package): 70797-308-04
ndc (package): 70797-308-01
ndc (product): 70797-308
ndc11 (package): 70797030801
ndc11 (package): 70797030804
spl id: c0963200-67de-6349-e053-2a95a90adde1
spl set id: c0963200-67dd-6349-e053-2a95a90adde1

Reported adverse events (FAERS/openFDA)#

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