DR. TALBOTS TUMMY ACHE RELIEF- calendula officinalis, carbo vegetabilis, chamomilla, cinchona officinalis, colocynthis, foeniculum vulgare, lycopodium, nux moschata, zingiber officinale, kali muriaticum, magnesia phosphorica, natrum phosphoricum liquid

Dr. Talbots Tummy Ache Relief by

Drug Labeling and Warnings

Dr. Talbots Tummy Ache Relief by is a Homeopathic medication manufactured, distributed, or labeled by Talbot's Pharmaceuticals Family Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredients

Calendula officinalis 6X HPUS

Carbo Vegetabilis 12X HPUS
Chamomilla 6X HPUS
Cinchona Officinalis 6X HPUS
Colocynthis 12X HPUS
Foeniculum Vulgare 6X HPUS
Lycopodium 30X HPUS
Nux Moschata 6X HPUS
Zingiber Officinale (Ginger) 6X HPUS

Cell Salts

Kali muriaticum 6X HPUS
Magnesia phosphorica 6X HPUS
Natrum phosphoricum 6X HPUS

Purpose

Purpose

Upset stomach

Nausea and vomiting

Abdominal pain associated with nervousness

Diarrhea

Abdominal colic type pain

Upset stomach

Gas, diarrhea
Indigestion
Stomach hyperacidity
Abdominal inflammation
Abdominal colic type pain
Stomach hyperacidity

Pregnancy or breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep out of reach of children

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.

Directions

• 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

Inactive Ingredients

Inactive ingredients

Apple juice, citric acid, glycerin, potassium sorbate, purified water

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Uses

Uses

Temporarily relieves infant discomfort caused by

• gas
• colic
• nausea
• stomach pressure and cramps
• diarrhea
• upset stomach
• nervous tummy
• indigestion
• minor stomach pain
• excessive stomach acid

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
• 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.

Principal Display Panel

INGREDIENTS AND APPEARANCE

DR. TALBOTS TUMMY ACHE RELIEF 
calendula officinalis, carbo vegetabilis, chamomilla, cinchona officinalis, colocynthis, foeniculum vulgare, lycopodium, nux moschata, zingiber officinale, kali muriaticum, magnesia phosphorica, natrum phosphoricum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70797-301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]  in 118 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	6 [hp_X]  in 118 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]  in 118 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_X]  in 118 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	6 [hp_X]  in 118 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X]  in 118 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X]  in 118 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	6 [hp_X]  in 118 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	6 [hp_X]  in 118 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	12 [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
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	6 [hp_X]  in 118 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70797-301-01	1 in 1 CARTON	11/01/2019
1	NDC: 70797-301-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
OHM Pharma Inc.		030572478	manufacture(70797-301) , pack(70797-301) , label(70797-301)