pharmacopeia

Maleate

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • Uses temporarily relieves: runny nose sneezing itchy, watery eyes due to hay fever itching of the nose or throat

Dosage & administration

Sourced from openFDA

Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product ml = milliliter age Dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use

Warnings & precautions

Sourced from openFDA

Do not use to sedate a child or to make a child sleepy Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, or chronic bronchitis. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 at 1-800-222-1222.

Approval history

Sourced from openFDA
  • Dec 24, 1985NDANDA018998Bausch
  • Nov 5, 1986NDANDA019463Bausch And Lomb Inc
  • Nov 4, 1993NDANDA020330Bausch And Lomb Inc
  • Jun 8, 1994NDANDA020226Alcon
  • Jan 31, 1996NDANDA020485Kenvue Brands
  • Apr 7, 1998NDANDA020869Thea Pharma
  • Oct 21, 1998NDANDA020963Sandoz
  • Dec 19, 2002NDANDA021441Haleon Us Holdings

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
139,423 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective10,0457.2%
  2. 2Fatigue8,2655.9%
  3. 3Nausea7,9515.7%
  4. 4Dyspnoea6,5544.7%
  5. 5Diarrhoea6,5304.7%
  6. 6Headache6,4374.6%
  7. 7Dizziness5,6044.0%
  8. 8Off Label Use5,3033.8%
  9. 9Pain5,1293.7%
  10. 10Vomiting4,7263.4%
  11. 11Asthenia4,1813.0%
  12. 12Pneumonia3,8792.8%
  13. 13Cough3,7562.7%
  14. 14Fall3,6592.6%
  15. 15Malaise3,5782.6%

Clinical trials

View JSON

The 10 most recently updated of 478 ClinicalTrials.gov registrations naming Maleate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Maleate used for?
According to FDA labeling, Maleate carries indications including: Uses temporarily relieves: runny nose sneezing itchy, watery eyes due to hay fever itching of the nose or throat. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
Note. Data for maleate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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