Label: TUMMY CALM (carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla- smilax regelii, zingiber officinale liquid
- NDC Code(s): 73282-0005-1
- Packager: CalmCo LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated June 5, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
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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.
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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:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS or COMMENTS?:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TUMMY CALM
carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla (smilax regelii), zingiber officinale liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-0005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 1 [hp_X] in 1 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 3 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 3 [hp_X] in 1 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 3 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X] in 1 mL RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH 3 [hp_X] in 1 mL SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 3 [hp_X] in 1 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73282-0005-1 1 in 1 CARTON 10/27/2021 1 59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/27/2021 Labeler - CalmCo LLC (079308308)
