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NDC 70797-0322-01 Dr Talbots Infant Daily Allergy Relief 12; 12; 12; 12; 12; 12; 12; 6; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL Details

Dr Talbots Infant Daily Allergy Relief 12; 12; 12; 12; 12; 12; 12; 6; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL

Dr Talbots Infant Daily Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Talbot's Pharmaceuticals Family Products,LLC.. The primary component is ANEMONE PULSATILLA; ARALIA RACEMOSA ROOT; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP.

Product Information

NDC	70797-0322
Product ID	70797-322_e8bdcc8a-c948-ff5d-e053-2a95a90a3b92
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dr Talbots Infant Daily Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	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
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12; 12; 12; 12; 12; 12; 12; 6; 12
Active Ingredient Units	[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL
Substance Name	ANEMONE PULSATILLA; ARALIA RACEMOSA ROOT; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP
Labeler Name	Talbot's Pharmaceuticals Family Products,LLC.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], O
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70797-0322-01 (70797032201)

Pricing Information	N/A
NDC Package Code	70797-322-01
Billing NDC	70797032201
Package	1 BOTTLE in 1 CARTON (70797-322-01) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e8bdcc8a-c947-ff5d-e053-2a95a90a3b92 Details

ACTIVE INGREDIENTS

Active 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 ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

PURPOSE

Temporarily Relieves:

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

PREGNANCY

If pregnant or breastfeeding, consult your doctor before use.

Keep out of reach of children.

DIRECTIONS

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

QUESTIONS

Questions or comments?

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

M-F 8am-5pm CST

ASK A DOCTOR

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.

Warnings

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.

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

Keep Out of Reach of Children

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.

PRINCIPAL DISPLAY

INGREDIENTS AND APPEARANCE

DR 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70797-322
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARALIA RACEMOSA ROOT (UNII: T90W4582DU) (ARALIA RACEMOSA ROOT - UNII:T90W4582DU)	ARALIA RACEMOSA ROOT	12 [hp_X] in 118 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	12 [hp_X] in 118 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	12 [hp_X] in 118 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X] in 118 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X] in 118 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 118 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	12 [hp_X] in 118 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	12 [hp_X] in 118 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X] in 118 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
CONCORD GRAPE JUICE (UNII: F7039Q79LP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70797-322-01	1 in 1 CARTON	09/12/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/12/2022

Labeler - Talbot's Pharmaceuticals Family Products,LLC. (078855555)

Revised: 9/2022

Document Id: e8bdcc8a-c948-ff5d-e053-2a95a90a3b92

Set id: e8bdcc8a-c947-ff5d-e053-2a95a90a3b92

Version: 1

Effective Time: 20220912