TUMMY CALM- carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale liquid 
CalmCo LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Tummy Calm

ACTIVE INGREDIENTS:

Carbo Vegetabilis 1X

Chamomilla 3X

Lycopodium 3X

Nux Moschata 3X

Passiflora 3X

Raphanus Sativus 3X

Sarsaparilla 3X

Zingiber Officinale 3X.

PURPOSE:

gas relief, hiccups

irritability, teething

gas relief, bloating

irritability, restlessness

gas relief, upset stomach

gas relief, upset stomach

gas relief, sour burping

digestive aid

WARNINGS:

Tamper Evident:do not use if carton is open, or wrap on oral dispenser is broken or missing.

Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs.

• As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product.

• Because product is black, a temporary, harmless, darkening of the stool may occur.

• May stain fabric; protect clothing and furniture.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Weight Dose

Under 20 lbs. (9kg) 1/4 teaspoon (1.25 mL)

Over 20 lbs. (9kg) 1/2 teaspoon (2.5 mL)

• Shake well before use.

• Remove protective wrap from oral dispenser.

• Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums.

• If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours.

• Recap bottle and clean dispenser after use.

• Discard remaining product after 3 weeks.

INDICATIONS:

Temporarily relieves the symptoms of pediatric:

digestive discomfort • gas • hiccups • reflux

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTHER INFORMATION:

• Please note: sleep may follow naturally after relief.

• Store at room temperature, out of direct sunlight.

INACTIVE INGREDIENTS:

Benzoic acid, citric acid (anhydrous), glycerin, potassium citrate, potassium sorbate, purified water, xanthan gum, xylitol

QUESTIONS or COMMENTS?:

Call 941-202-3270 or visit

www.DrKids.com

PACKAGE LABEL DISPLAY:

Tummy calm outerTummy calm inner

TUMMY CALM 
carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE3 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]  in 1 mL
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH3 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT3 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0005-11 in 1 CARTON10/27/2021
159 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/27/2021
Labeler - CalmCo LLC (079308308)

Revised: 6/2023
Document Id: fd6759e7-ea24-ff5f-e053-6294a90a265b
Set id: 0fa9a21e-f0d8-4596-9e72-0d69207292a2
Version: 2
Effective Time: 20230605
 
CalmCo LLC