Search by Drug Name or NDC

NDC 70797-0321-01 Dr Talbots Infant Pain Inflamtion Relief 12; 12; 12; 12; 12; 12; 6; 12; 6 [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 Pain Inflamtion Relief 12; 12; 12; 12; 12; 12; 6; 12; 6 [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 Pain Inflamtion Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Talbot. The primary component is ARABICA COFFEE BEAN; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; POTASSIUM CHLORIDE.

Product Information

NDC	70797-0321
Product ID	70797-321_e892c0cb-03b5-52da-e053-2995a90a0878
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 Pain Inflamtion Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica 12X,Bellis perennis 12X,Calendula officinalis 12X,Chamomilla 12X,Coffea cruda 12X,Hypericum 12X,Millefolium 12X,Ferrum phosphoricum 12X,Kali muriaticum 6X,Magnesia phosphorica 6X
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12; 12; 12; 12; 12; 12; 6; 12; 6
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	ARABICA COFFEE BEAN; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; POTASSIUM CHLORIDE
Labeler Name	Talbot
Pharmaceutical Class	Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Ele
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70797-0321-01 (70797032101)

Pricing Information	N/A
NDC Package Code	70797-321-01
Billing NDC	70797032101
Package	1 BOTTLE in 1 CARTON (70797-321-01) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e892c0cb-03b4-52da-e053-2995a90a0878 Details

ACTIVE INGREDIENTS

Active ingredients (HPUS)

Arnica 12X

Bellis perennis 12X

Calendula officinalis 12X

Chamomilla 12X

Coffea cruda 12X

Hypericum 12X

Millefolium 12X

Cell Salts

Ferrum phosphoricum 12X

Kali muriaticum 6X

Magnesia phosphorica 6X

INACTIVE INGREDIENTS

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

PREGNANCY

Pregnant or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

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 immediately for a worsening condition.

QUESTIONS

Questions or comments?

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

M-F 8am-5pm CST

Purpose

Temporarily Relieves:

Toothache
Nerve Pain from Trauma
Growing, Joint, & Muscular Pain
Bruising & SWelling

Usage

Uses:

Temporarily relieves minor aches and pains due to:

toothache
muscle pain and swelling
bruises
nerve pain
vascular pain
joint and bone pain
inflamation and swelling from trauma

Dosage

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for upto 8 doses until symtoms relieved, every 2 hours thereafter.

Children Dose

6 - 18 lbs or 3 - 8 kgs 1.25 mL every 2 hours*

19 - 29 lbs or 9 - 13 kgs 2.5 mL every 2 hours*

30 - 90 lbs or 14 - 41 kgs 5 mL every 2 hours*

*Reduce frequency when symptoms improve.

Warning

Warnings:

Stop use and ask a doctor if:

fever develops, worsens, or lasts more than 3 days
pain gets worse or lasts more than 7 days
other symtoms persist for more than 7 days or worsen

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 Panel

INGREDIENTS AND APPEARANCE

DR TALBOTS INFANT PAIN INFLAMTION RELIEF

arnica 12x,bellis perennis 12x,calendula officinalis 12x,chamomilla 12x,coffea cruda 12x,hypericum 12x,millefolium 12x,ferrum phosphoricum 12x,kali muriaticum 6x,magnesia phosphorica 6x liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70797-321
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	12 [hp_X] in 118 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 118 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	12 [hp_X] in 118 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	12 [hp_X] in 118 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	6 [hp_X] in 118 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	6 [hp_X] in 118 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X] in 118 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	12 [hp_X] in 118 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X] in 118 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70797-321-01	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: e892c0cb-03b5-52da-e053-2995a90a0878

Set id: e892c0cb-03b4-52da-e053-2995a90a0878

Version: 1

Effective Time: 20220912