The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Acidcalm (NDC 0220-9106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each pellet)
Abies nigra 4C HPUS (0.11 mg)
Carbo vegetabilis 4C HPUS (0.11 mg)
Nux vomica 4C HPUS (0.11 mg) (contains less than 10 -10 mg strychnine alkaloids)
Robinia pseudoacacia 4C HPUS (0.11 mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Abies nigra 4C HPUS (0.11 mg) ... Relieves stomach pain after eating
Carbo vegetabilis 4C HPUS (0.11 mg) ... Relieves stomach bloating with gas
Nux vomica 4C HPUS (0.11 mg) ... Relieves heartburn due to excessive eating and drinking
Robinia pseudoacacia 4C HPUS (0.11 mg) ... Relieves heartburn with acid indigestion
Uses*
temporarily relieves:
heartburn
acid indigestion
bloating
upset stomach associated with these symptoms
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen. If you have trouble swallowing or persistent abdominal pain, see your doctor promptly.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
lactose, sucrose
1-800-264-7661
Made in France
Distributed by
Boiron, Inc.
Newtown Square, PA 19073
MULTI-SYMPTOM
HEARTBURN RELIEF*
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Plant-Powered Relief
Meltaway Pellets
Contains approx. 80 pellets, 3.8 g (0.13 oz)
Turn tube upside down
Twist until 5 pellets are dispensed
Remov cap and pour pellets under the tongue
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
