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NDC 70797-0320-01 Dr Talbots Infant Mucus Cold Relief 12; 12; 12; 12; 12; 12; 30; 6; 12; 12; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_Q]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL Details

Dr Talbots Infant Mucus Cold Relief 12; 12; 12; 12; 12; 12; 30; 6; 12; 12; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_Q]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL

Dr Talbots Infant Mucus Cold Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Talbot. The primary component is ANEMONE PULSATILLA; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; MARRUBIUM VULGARE; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP.

Product Information

NDC	70797-0320
Product ID	70797-320_e8917c54-f4c3-3427-e053-2995a90adbf2
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 Mucus Cold Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Eupatorium perf 12X,Hepar sulphuris calcareum 12X,Kali bichromicum 12X,Marrubium vulgare 12X,Phosphorus 30X,Pulsatilla 12X,Rumex crispus 12X,Sambucus nigra 12X,Calcarea sulphurica 12X,Ferrum phosphoricum 12X
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12; 12; 12; 12; 12; 12; 30; 6; 12; 12; 12
Active Ingredient Units	[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_Q]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL
Substance Name	ANEMONE PULSATILLA; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; MARRUBIUM VULGARE; PHOSPHORUS; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP
Labeler Name	Talbot
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxat
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70797-0320-01 (70797032001)

Pricing Information	N/A
NDC Package Code	70797-320-01
Billing NDC	70797032001
Package	1 BOTTLE in 1 CARTON (70797-320-01) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e8917c54-f4c2-3427-e053-2995a90adbf2 Details

ACTIVE INGREDIENT

Active ingredients (HPUS)

Eupatorium perf 12X

Kali bichromicum 12X

Marrubium vulgare 12X

Phosphorus 30X

Pulsatilla 12X

Rumex crispus 12X

Sambucus nigra 12X

Cell Salts

Calcarea sulphurica 12X

Ferrum phosphoricum 12X

Kali muriaticum 6X

PREGNACY

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 conditions.

Please counsult your physcian immidiately for a worsening condition.

INACTIVE INGREDIENTS

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

QUESTIONS

Questions or comments?

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

M-F 8am-5pm CST

Warnings

Warnings:

Do not use:

for persistent or chronic cough
for treating cough from asthma, smoking, or emphysema
for treating cough with excessive mucus.

A persistent may be a sign of a serious condition.

Stop use and ask doctor if:

cough/congestion lasts for more than 7 days.
cough/congestion comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition.
other symptoms persist for more than 7 days or worsen.

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 up to 8 doses until symptoms 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.

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.

Uses

Uses:

Temporarily relieves

cough and congestion associated with colds
mucus in chest
mucuy cough
runny nose
sneezing
nasal and sinus congestion

Purpose

Temporarily Relieves:

Thick Mucus
Runny Nose & Cough
Nasal & Chest Congestion
Sinus Inflammation

PRICIPAL DISPLAY PANEL

Label:

INGREDIENTS AND APPEARANCE

DR TALBOTS INFANT MUCUS COLD RELIEF

eupatorium perf 12x,hepar sulphuris calcareum 12x,kali bichromicum 12x,marrubium vulgare 12x,phosphorus 30x,pulsatilla 12x,rumex crispus 12x,sambucus nigra 12x,calcarea sulphurica 12x,ferrum phosphoricum 12x liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70797-320
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MARRUBIUM VULGARE (UNII: 7A72MUN24Z) (MARRUBIUM VULGARE - UNII:7A72MUN24Z)	MARRUBIUM VULGARE	12 [hp_Q] in 118 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	12 [hp_X] in 118 mL
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE ANHYDROUS	12 [hp_X] in 118 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	6 [hp_X] in 118 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	12 [hp_X] in 118 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X] in 118 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	12 [hp_X] in 118 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X] in 118 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X] in 118 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	12 [hp_X] in 118 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X] in 118 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70797-320-01	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: e8917c54-f4c3-3427-e053-2995a90adbf2

Set id: e8917c54-f4c2-3427-e053-2995a90adbf2

Version: 1

Effective Time: 20220913