Quick answers
- What is Water-miscible retinyl palmitate used for?
- The FDA-approved label (AQUASOL A Parenteral, Rising Pharma Holdings, Inc., March 3, 2026) says: “INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Water-miscible retinyl palmitate?
- The “Adverse Reactions” section of the FDA label (AQUASOL A Parenteral, Rising Pharma Holdings, Inc., March 3, 2026) begins: “See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A ® Parenteral including one case of an anaphylactoid type reaction. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Water-miscible retinyl palmitate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Water-miscible retinyl palmitate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Water-miscible retinyl palmitate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Water-miscible retinyl palmitate?
- 1 company lists prescription products of Water-miscible retinyl palmitate in the FDA NDC Directory, including Rising Pharma Holdings, Inc.
What Water-miscible retinyl palmitate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS Retinyl palmitate injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea. Pediatric Use …
— FDA label: AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intramuscular), AQUASOL A Parenteral, Rising Pharma Holdings, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Water-miscible retinyl palmitate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A ® Parenteral including one case of an anaphylactoid type reaction. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026. Read the full label on DailyMed →
Water-miscible retinyl palmitate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
For intramuscular use. I. Adults 100,000 Units daily for three days followed by 50,000 Units daily for two weeks. II. Pediatric patients 1 to 8 years old 17,500 to 35,000 Units daily for 10 days. III. Infants 7,500 to 15,000 Units daily for 10 days.
Read more of this section
Follow-up therapy with an oral therapeutic multivitamin preparation, containing 10,000 to 20,000 Units vitamin A for adults and for pediatric patients over 8 years old, and 5,000 to 10,000 Units for infants and other pediatric patients under 8 years old, is recommended daily for two months. Low birth-weight infants may require additional retinyl palmitate though the exact dosing in these pediatric patients has not been established. In malabsorption, the parenteral route must be used for an equivalent preparation. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.
— FDA label: AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026. Read the full label on DailyMed →
When Water-miscible retinyl palmitate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation. Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A in excess of the recommended dietary allowance may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have shown fetal abnormalities associated with overdosage in several species.
Read more of this section
Malformations of the central nervous system, the eye, the palate, and the urogenital tract are recorded. Vitamin A in excess of the recommended dietary allowance is contraindicated in women who are or may become pregnant. If vitamin A is used during pregnancy, or if the patient becomes pregnant while taking vitamin A, the patient should be apprised of the potential hazard to the fetus.
— FDA label: AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026. Read the full label on DailyMed →
Water-miscible retinyl palmitate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
The following amounts have been found to be toxic orally. Toxicity manifestations depend on the age, dosage, size, and duration of administration. Acute toxicity — single dose (25,000 Units/kg body weight) Infant: 350,000 Units Adult: Over 2 million Units Chronic toxicity (4,000 Units/kg body weight for 6 to 15 months) Infants 3 to 6 months old: 18,500 Units (water dispersed)/day for 1 to 3 months.
Read more of this section
Adult: 1 million Units daily for three days; 50,000 Units daily for longer than 18 months; 500,000 Units daily for two months. Hypervitaminosis A Syndrome: 1. General manifestations: Fatigue, malaise, lethargy, abdominal discomfort, anorexia, and vomiting. 2. Specific manifestations: a. Skeletal: hepatotoxicity, hard tender cortical thickening over the radius and tibia, migratory arthralgia, slow growth, and premature closure of the epiphysis leading to arrested bone growth in children. b. Central Nervous System: irritability, headache, and increased intracranial pressure as manifested by bulging fontanels, papilledema, and exophthalmos. c. Dermatologic: fissures of the lips, drying and cracking of the skin, alopecia, scaling, massive desquamation, and increased pigmentation. d. Systemic: hypomenorrhea, hepatosplenomegaly, hepatotoxicity, jaundice, leukopenia, retinyl palmitate plasma level over 1,200 Units/100 mL. The treatment of hypervitaminosis A consists of immediate withdrawal of the vitamin along with symptomatic and supportive treatment.
— FDA label: AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intramuscular |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Aquasol a Parenteral |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA006823 AQUASOL A | Casper Pharma LLC | May 18, 1949 | 13, latest September 18, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2000: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 210972, 313650 |
|---|---|
| SPL set ID of the quoted label | 1abd66eb-6ac8-4a9e-a609-251e46ea1a27 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA006823 |
| Active ingredients (FDA) | VITAMIN A PALMITATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Rising Pharma Holdings, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — AQUASOL A Parenteral, Rising Pharma Holdings, Inc., effective March 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →