Citric Acid is an active pharmaceutical ingredient in the Acid Preparations group (A09AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 24, 2013[1]
The symptomatic treatment of coughs and sore throats.
How to take
GBOfficial regulatory label
USUnited States· FDA
5 products
Uses
USOfficial regulatory label· revised January 15, 2025[2]
Uses For the relief of Heartburn, acid indigestion, and upset stomach associated with these symptoms.
How to take
US
CACanada· Health Canada
3 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
5 g; sodium picosulfate 10 mg None. For a complete listing see the Dosage Forms, Composition and Packaging section of the product monograph. General The active components of PICO-SALAX® are sodium picosulfate and magnesium citrate. Picosulfate (a pro-drug) is a stimulant cathartic active locally in the colon.
Magnesium citrate (magnesium oxide and citric acid) acts as an osmotic laxative by retaining moisture in the colon. The action is of a powerful “washing out” effect combined with peristaltic stimulation to clear the bowel prior to radiography, colonoscopy or surgery.
Full doses of the saline cathartics (15 g of magnesium sulfate or its equivalent) produces a semi-fluid or watery evacuation within 3-6 hours or less. The product is not intended for routine use as a laxative. Some absorption of the component ions of the saline cathartics does occur, and in certain instances they may produce systemic toxicity.
This is especially true for magnesium salts, since 20% or more of the administered cation is absorbed. If renal function is normal, the absorbed magnesium is rapidly excreted. However, if a magnesium cation is given to an individual with impaired renal function, the accumulation of magnesium ion in the body fluids may be sufficient to cause magnesium intoxication.
Drug interactions
Known interactions involving Citric Acid. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]FDA DailyMed · 04a27a71-b7b2-12… · revised January 15, 2025 [PDF]
[3]Health Canada (DPD) · 02254794 · revised March 22, 2025
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
For oral administration Adults and the elderly Two 5 ml spoonfuls to be taken 3 or 4 times daily. Children over 1 year One 5 ml spoonful to be taken 3 or 4 times daily. Not recommended for infants under 1 year.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 24, 2013[1]
None anticipated at the recommended dosage.
GBOfficial regulatory label· Warnings and precautions· revised May 24, 2013[1]
This product is not suitable for use by diabetics. If symptoms persist, consult your doctor.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 24, 2013[1]
Hypersensitivity to any of the ingredients. Patients with rare hereditary problems or fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Not recommended for infants under 1 year.
This is not medical advice. Consult a qualified healthcare professional.
Directions Adults 18 years of age and over: take up 1 chewable and repeat every 6 to 8 hours or as directed by a physician Do not swallow whole
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 186 reports total. [4]
Drug Ineffective 41
Headache 38
Activated Partial Thromboplastin Time Prolonged 37
Fatigue 37
Congenital Hiatus Hernia 36
Drug Hypersensitivity 35
Off Label Use 35
Somnolence 35
Condition Aggravated 34
Drug Intolerance 34
Swelling 34
Anaemia 33
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 15, 2025[2]
Stop using and ask a doctor if Presently taking a prescription drug, Antacids may interact with certain prescription drugs
USOfficial regulatory label· Warnings and precautions· revised January 15, 2025[2]
Warnings Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician Do not use Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician Ask a doctor before use if you are Presently taking a prescription drug, Antacids may interact with certain prescription drugs Stop using and ask a doctor if Presently taking a prescription drug, Antacids may interact with certain prescription drugs If pregnant or breast-feeding consult a health professional before use Keep out of reach of children In case of overdose seek medical help or contact a poison control center right away Keep out of reach of children In case of overdose, seek medical help or contact a poison control center right away
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 15, 2025[2]
Do not use Do not take more than 4 chewables in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
This is not medical advice. Consult a qualified healthcare professional.
In most instances, salts that gain access to the systemic circulation are rapidly excreted by the kidneys. PICO-SALAX (sodium picosulfate, magnesium oxide and citric acid) Page 4 of 14 INDICATIONS AND CLINICAL USE PICO-SALAX is indicated for clearance of the bowel prior to x-ray examination, endoscopy or surgery.
CONTRAINDICATIONS PICO-SALAX is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of this document.
• Patients with congestive cardiac failure, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro -intestinal obstruction or perforation.
• Patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases. WARNINGS AND PRECAUTIONS General Care should also be taken in patients with recent gastro-intestinal surgery, renal impairment, heart disease or inflammatory bowel disease.
g. diuretics, corticosteroids, lithium [see Drug Interactions and Adverse Reactions]. g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy [see Drug Interactions and Adverse Reactions].
Patients should avoid taking oral iron preparations for a week before colon oscopy. g. cholinergics, opioids) should be suspended for a few days before the procedure, after consulting with your doctor. An inadequate oral intake of water and electrolytes could create clinically significant deficiencies, particularly in less fit patients.
In this regard, the elderly, debilitated individuals and patients at risk of hypokalaemia may need particular attention. Prompt corrective action should be taken to restore fluid/electrolyte balance in patients with signs or symptoms of hyponatraemia.
The period of bowel cleansing should not exceed 24 hours because longer preparation time may increase the risk of water and electrolyte imbalance. PICO-SALAX (sodium picosulfate, magnesium oxide and citric acid) Page 5 of 14 Serious Fluid and Serum Chemistry Abnormalities Advise patients to hydrate adequately before, during and after the use of PICO-SALAX.
Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PICO-SALAX, consider performing post-colonoscopy lab tests (electrolytes, creatinine and BUN) and treat accordingly.
Approximately 20% of patients in clinical trials had orthostatic changes (changes in blood pressure and/or heart rate) on the day of colonoscopy; however these changes were not clinically relevant. In clinical trials orthostatic changes were documented out to seven days post colonoscopy [see Adverse Reactions].
Fluid and electrolyte disturbances can lead to serious adverse events […]