Label: TUMMY CALM (carbo vegetabilis, chamomilla, lycopodium clavatum, nux moschata, passiflora incarnata, raphanus sativus, sarsaparilla- smilax regelii, zingiber officinale liquid
- Label RSS
- Share
- NDC Code(s): 73282-0005-1
- Packager: CalmCo LLC
- Category: HUMAN OTC DRUG LABEL
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 October 27, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
-
WARNINGS:
• Do not use if outer seal on glass bottle or protective 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. In case of overdose, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN:
-
DIRECTIONS:
Weight Dose
Under 20 lbs. (9kg) 1/4 teaspoon (1.25 mL)
Over 20 lbs. (9kg) 1/2 teaspoon (2.5 mL)• Remove outer seal from glass bottle and protective wrap from oral dispenser.
• Shake well before use.
• 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:
- PACKAGE LABEL DISPLAY:
-
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) POTASSIUM BENZOATE (UNII: 763YQN2K7K) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) 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) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(73282-0005) , api manufacture(73282-0005) , label(73282-0005) , pack(73282-0005)
