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NDC 70797-0323-01 Dr Talbots Infgant Gas Colic Relief 12; 12; 12; 30; 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; [hp_X]/118mL Details

Dr Talbots Infgant Gas Colic Relief 12; 12; 12; 30; 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; [hp_X]/118mL

Dr Talbots Infgant Gas Colic 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 ACTIVATED CHARCOAL; FENNEL SEED; GINGER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; NUTMEG; POTASSIUM CHLORIDE; RADISH; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE.

Product Information

NDC	70797-0323
Product ID	70797-323_e8bee190-04b3-4be6-e053-2a95a90a30a0
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 Infgant Gas Colic Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carbo vegetabilis 12X,Chamomilla 12X,Foeniculum vulgare 12X,Lycopodium 30X,Nux moschata 12X,Raphanus sativus 12X,Zingiber officinale 12X,Kali muriaticum 6X,Magnesia phosphorica 12X,Natrum phosphoricum 6X
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	12; 12; 12; 30; 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; [hp_X]/118mL
Substance Name	ACTIVATED CHARCOAL; FENNEL SEED; GINGER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; NUTMEG; POTASSIUM CHLORIDE; RADISH; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Labeler Name	Talbot's Pharmaceuticals Family Products,LLC.
Pharmaceutical Class	Allergens [CS], Allergens [CS], Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70797-0323-01 (70797032301)

Pricing Information	N/A
NDC Package Code	70797-323-01
Billing NDC	70797032301
Package	1 BOTTLE in 1 CARTON (70797-323-01) / 118 mL in 1 BOTTLE
Marketing Start Date	2022-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e8bee190-04b2-4be6-e053-2a95a90a30a0 Details

ACTIVE INGREDIENTS

Active ingredients (HPUS)

Carbo vegetabilis 12X

Chamomilla 12X

Foeniculum vulgare 12X

Lycopodium 30X

Nux moschata 12X

Raphanus sativus 12X

Zingiber officinale 12X

Cell Salts

Kali muriaticum 6X

Magnesia phosphorica 12X

Natrum phosphoricum 6X

INACTIVE INGREDIENTS

Inactive ingredients

Apple juice, citric acid, glycerin, potassium

sorbate, purified water

PREGNANCY

If pregnant or breastfeeding, consult your doctor before use.

ASK A DOCTOR

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

Please consult your physician immiediately for a worsening condition.

QUESTIONS

Questions or comments?

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

M-F 8am-5pm CST

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.

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.

Uses

Uses: Temporarily relieves infant discomfort caused by

gas
nausea
fussiness
colic
indigestion
burping
groaning
restlesness
sleeplessness
diarrhea
crying
constipation
ecxessive stomach acid
bloating
stomach discomfort and presure

PURPOSE

Temprorily Relieves:

Colic Gas Pain
Stomach & Gas Discomfort
Irritability from Gas
Stomach Acid Buildup

WARNINGS

Warnings:

Stop use and ask doctor if:

fever develops.
diarrhea lasts more than 2 days.
other symptoms persist for more than 7 days or worsen.

PRINCIPAL DISPLAY PANEL

Label Display:

INGREDIENTS AND APPEARANCE

DR TALBOTS INFGANT GAS COLIC RELIEF

carbo vegetabilis 12x,chamomilla 12x,foeniculum vulgare 12x,lycopodium 30x,nux moschata 12x,raphanus sativus 12x,zingiber officinale 12x,kali muriaticum 6x,magnesia phosphorica 12x,natrum phosphoricum 6x liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70797-323
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	6 [hp_X] in 118 mL
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463)	RADISH	12 [hp_X] in 118 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	12 [hp_X] in 118 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X] in 118 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	12 [hp_X] in 118 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X] in 118 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	12 [hp_X] in 118 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	12 [hp_X] in 118 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	6 [hp_X] in 118 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 118 mL

Ingredient Name	Strength
Inactive Ingredients
APPLE JUICE (UNII: 9871T0PD5P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70797-323-01	1 in 1 CARTON	09/28/2022
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		09/28/2022

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

Revised: 9/2022

Document Id: e8bee190-04b3-4be6-e053-2a95a90a30a0

Set id: e8bee190-04b2-4be6-e053-2a95a90a30a0

Version: 1

Effective Time: 20220928