Home › NDC Lookup › Ingredients › Doxycycline › 43547-0590-03
💊image loading
(from DailyMed)

Doxycycline 40 mg Capsule, 30-count — NDC 43547-590-03 (Billing 43547-0590-03)

by Solco Healthcare US,LLC · 30 CAPSULE in 1 BOTTLE

This is a package of 30 capsules of Doxycycline 40 mg Capsule from Solco Healthcare US,LLC, marketed since Dec 2025 and currently FDA-listed; retail pharmacies pay about $4.67 per capsule (NADAC). It is this product's only package size.

NDC 43547-0590-03
🏷️ FDA NDC (as labeled) 43547-590-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43547-590-03
Product NDC 43547-590
11-digit billing NDC 43547059003
NCPDP billing unit EA — each (per item)
RxCUI 901399
UNII N12000U13O
UPC 0343547590031
Application # ANDA217098
SPL Set ID 99305d9a-d058-45d6-8dec-19308b1fc5a9
Established class (EPC) Tetracycline-class Drug
Chemical class Tetracyclines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-15
Route ORAL
Dosage form CAPSULE
Substance DOXYCYCLINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90060025006520
GCN Seq No 060942
GCN 27097
HICL code 004014
Ingredient (HICL) Doxycycline Monohydrate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1C
Therapeutic class — specific (HIC3) Tetracycline Antibiotics
AHFS code 08:12.24.00
AHFS class Tetracycline Antibiotics
FDB label name DOXYCYCLINE IR-DR 40 MG CAP
FDB brand name Doxycycline Ir-Dr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060942
  • GCN: 27097
  • GPI-14 (Medi-Span): 90060025006520
  • HICL (First Databank): 004014
  • AHFS class code: 08:12.24.00
  • RxCUI (RxNorm): 901399
Why two NDCs? The FDA registers this code as 43547-590-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43547-0590-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Tetracycline-class Drug class.

Pharmacologic class Tetracycline-class Drug
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Tetracyclines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DOXYCYCLINE IR-DR 40 MG CAP Ingredient Doxycycline Monohydrate
📗 Our plain-language guide HelloPharmacist
  • It is an antibiotic for bacterial infections such as rickettsial infections, sexually transmitted infections, respiratory tract infections and eye infections. Some products are als...
  • Take it exactly as your prescriber and label say. Swallow capsules with a full glass of water and avoid taking them right before lying down. For one capsule product, take it at lea...
  • Diarrhea, nausea, vomiting, stomach upset and loss of appetite are the most common. You may also sunburn much more easily, so cover up and avoid tanning beds. Call me or your docto...
  • Call right away for severe or watery diarrhea, a blistering or peeling rash, headache with vision changes, trouble swallowing, or signs of an allergic reaction. Diarrhea can show u...
📖 Read our full Doxycycline guide →
7
Nutrient depletion considerations

Doxycycline may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Doxycycline nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $4.671 $140.12 / 30 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $14.01 $420.21 / 30 capsules
NADAC price history (per ea) — tap or hover for the price & month
May 2026 Jun 2026 Jul 2026 Sep 2026 $6.735 $4.295
▼ Down 31% over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43547-0590-03 You're viewing this Main listing 30 CAPSULE in 1 BOTTLE 2025-12-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doxycycline 40 mg 11788-0134-30 AiPing 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mgthis 43547-0590-03 Solco 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 43598-0457-30 Dr.Reddys 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 60505-4775-03 Apotex 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 62332-0785-30 Alembic 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 68308-0668-30 Mayne 30 capsules $4.671 AB Availability likely —
Doxycycline 40 mg 70748-0308-06 Lupin 30 capsules $4.671 AB Availability likely —
Oracea 40 mg 00299-3822-02 Galderma 192 capsules — AB Discontinued —
doxycycline 40 mg 33342-0346-07 Macleods 30 capsules — AB FDA listed —
Doxycycline 40 mg 46708-0785-30 Alembic 30 capsules — AB FDA listed —
Doxycycline 40 mg 73190-0040-30 AvKARE 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSolco Healthcare US,LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA217098 (ANDA)
Labeler code43547
First marketedDec 2025
Product typeHuman Prescription Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 219 words ▾

1 INDICATIONS AND USAGE Click here to enter Indications Doxycycline capsules are a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ( 1.1 ) Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.

( 1.2 ) Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. ( 1.2 )

1.1Indication Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

1.2Limitations of Use This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline capsules should be used only as indicated.

Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

⏱️ Dosage and Administration 175 words ▾

2 DOSAGE AND ADMINISTRATION Click here to enter Dosage and Administration Take one doxycycline capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. ( 2.1 ) Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms. ( 2.2 , 5.9 )

2.1General Dosing Information Take one doxycycline capsule (40 mg) once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [ see Adverse Reactions ( 6 ) ].

2.2Important Considerations for Dosing Regimen The dosage of doxycycline capsules differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms. Generic Section [Enter Generic Section here]

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS 40 mg opaque, hard capsule. Light yellow opaque cap imprinted with “59” in black and white opaque body imprinted with “40mg” in black. The contents contain yellow beads and beige beads. 40 mg capsule. ( 3 )

⛔ Contraindications 36 words ▾

4 CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. Doxycycline capsules are contraindicated in persons who have shown hypersensitivity to doxycycline or other tetracyclines. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Click here to enter Warnings and Precautions • The use of doxycycline capsules during tooth development (the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth. ( 5.1 , 5.2 , 8.1 , 8.4 ) • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile . If C. difficile associated diarrhea occurs, discontinue doxycycline capsules.

( 5.3 ) • If renal impairment exists, doxycycline capsules doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury. ( 5.4 ) • Photosensitivity can occur with doxycycline capsules; Patients should minimize or avoid exposure to natural or artificial sunlight. ( 5.5 ) • Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue doxycycline capsules immediately.

( 5.6 ) • Doxycycline capsules may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue doxycycline capsules if symptoms occur. ( 5.8 ) • Bacterial resistance to tetracyclines may develop in patients using doxycycline capsules.

It should only be used as indicated. ( 5.9 ) 5. 1 Inhibition of Bone Growth During Fetal and Pediatric Development Doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, and childhood.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

If doxycycline is used during the second or third trimester of pregnancy, advise the patient of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )].

5.2Tooth Discoloration During Fetal and Pediatric Development The use of tetracycline class drugs orally during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported.

Use of tetracycline drugs is not recommended during tooth development [see Use in Specific Populations ( 8.1 )].

5.3Clostridium difficile Associated Diarrhea (CDAD) Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate management should be instituted as clinically indicated.

5.4Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral o… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Click here to enter Adverse Reactions Some of the most common adverse reactions (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of doxycycline capsules: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received doxycycline capsules or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥ 1% for the active arm: Table 1.

Incidence (%) of Selected Adverse Reactions in Clinical Trials of Doxycycline Capsules (n=269) vs. Placebo (n=268) Doxycycline Capsules Placebo Nasopharyngitis 13 (5) 9 (3) Pharyngolaryngeal Pain 3 (1) 2 (1) Sinusitis 7 (3) 2 (1) Nasal Congestion 4 (2) 2 (1) Fungal Infection 5 (2) 1 (0) Influenza 5 (2) 3 (1) Diarrhea 12 (5) 7 (3) Abdominal Pain Upper 5 (2) 1 (0) Abdominal Distention 3 (1) 1 (0) Abdominal Pain 3 (1) 1 (0) Stomach Discomfort 3 (1) 2 (1) Dry Mouth 3 (1) 0 (0) Hypertension 8 (3) 2 (1) Blood Pressure Increase 4 (2) 1 (0) Aspartate Aminotransferase Increase 6 (2) 2 (1) Blood Lactate Dehydrogenase Increase 4 (2) 1 (0) Blood Glucose Increase 3 (1) 0 (0) Anxiety 4 (2) 0 (0) Pain 4 (2) 1 (0) Back Pain 3 (1) 0 (0) Sinus Headache 3 (1) 0 (0) Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses: Gastrointestinal : anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity. Esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class.

Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [ see Dosage and Administration ( 2 ) ]. Renal toxicity : Rise in BUN has been reported and is apparently dose-related [ see Warnings and Precautions ( 5.4 ) ]. Skin : maculopapular and erythematous rashes.

Exfoliative dermatitis. Photosensitivity is discussed above [ see Warnings and Precautions ( 5.5 ) ]. Hypersensitivity reactions : urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia.

6.2Postmarketing Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of doxycycline capsules. Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.

Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache. Skin : fixed drug eruption Psychiatric : depression, anxiety, suicidal ideation, insomnia, abnormal dreams, hallucination

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Click here to enter Drug Interactions • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) • Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. ( 7.2 ) • The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

( 7.3 )

7.1Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

7.4Antacids and Iron Preparations Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.5Oral Retinoids There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

7.6Barbiturates and Anti-epileptics Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

7.7Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Click here to enter Use in Specific Populations Lactation: Breastfeeding is not recommended ( 8.2 )

8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 )]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline capsules during the second and third trimester of pregnancy.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.

Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

8.2Lactation Risk Summary Based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. There is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. Because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline capsules and for 5 days after the last dose.

8.4Pediatric Use Doxycycline capsules should not be used in infants and children less than 8 years of age [ see Warnings and Precautions ( 5.1 ) ]. Doxycycline capsules have not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

8.5Geriatric Use Clinical studies of doxycycline capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

🤰 Pregnancy 220 words ▾

8.1Pregnancy Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 )]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline capsules during the second and third trimester of pregnancy.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short- term courses.

Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

🧒 Pediatric Use 52 words ▾

8.4Pediatric Use Doxycycline capsules should not be used in infants and children less than 8 years of age [ see Warnings and Precautions ( 5.1 ) ]. Doxycycline capsules have not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

🧓 Geriatric Use 82 words ▾

8.5Geriatric Use Clinical studies of doxycycline capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY Click here to enter Clinical Pharmacology

12.1Mechanism of Action The mechanism of action of doxycycline capsules in the treatment of inflammatory lesions of rosacea is unknown.

12.3Pharmacokinetics Doxycycline capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline capsules were investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for doxycycline capsules following single oral doses and at steady-state in healthy subjects are presented in Table 2.

Table 2. Pharmacokinetic Parameters [Mean (±SD)] for Doxycycline Capsules N Cmax* (ng/mL) Tmax + (hr) AUC 0-oo * (ng•hr/mL) t 1/2 * (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3.00 (1.0-4.1) 9227± 3212.8 21.2 ±

7.6Steady-State# 40 mg capsules 31 600 ± 194.2 2.00 (1.0-4.0) 7543 ± 2443.9 23.2 ± 6.2 *Mean + Median # Day 7 Absorption: In a single-dose food-effect study involving administration of doxycycline capsules to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if doxycycline capsules are taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.

Distribution: Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of doxycycline capsules.

Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients [ see Warnings and Precautions ( 5.1 ) ]. Gender: The pharmacokinetics of doxycycline capsules were compared in 16 male and 14 female subjects under fed and fasted conditions.

While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function.

Hemodialysis does not alter the serum half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH.

This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric. Drug Interactions: [ see Drug Interactions ( 7 ) ].

12.4Microbiology Doxycycline is a member of the tetracycline-class of drugs. The plasma concentrations of doxycycline achieved with doxycycline capsules during administration [ see Clinical Pharmacology ( 12.3 ) and Dosage and Administration ( 2.2 ) ] are less than the concentration required to treat bacterial diseases. Doxycycline capsules should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease [ see Indications and Usage ( 1.2 ) ].

In vivo microbiological studies utilizing a similar dru… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action The mechanism of action of doxycycline capsules in the treatment of inflammatory lesions of rosacea is unknown.

📦 How Supplied / Storage and Handling 89 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Doxycycline capsules (Opaque, hard capsule. Light yellow opaque cap imprinted with “59” in black and white opaque body imprinted with “40mg” in black. The contents contain yellow beads and beige beads.) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.

Bottle of 30 (NDC 43547-590-03). Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) and dispensed in tight, light-resistant containers. [See USP Controlled Room Temperature]. Keep out of reach of children.

📋 Description 160 words ▾

11 DESCRIPTION Doxycycline capsules, 40 mg are a hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate.

It is very slightly soluble in water. Inert ingredients in the formulation are: gelatin, hypromellose, Ink SW9008 Black/black edible ink, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. The Ink SW9008 Black/black edible ink contains black iron oxide, propylene glycol, potassium hydroxide, and shellac.

FDA approved dissolution test specifications differ from USP. formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) Patients taking doxycycline capsules 40 mg should receive the following information and instructions: ● Advise pregnant women that doxycycline, like other tetracycline-class drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions ( 5.1 and 5.2 ) and Use in Specific Populations ( 8.1 )]. ● Advise women not to breastfeed during treatment with doxycycline capsules and for 5 days after the last dose [see Use in Specific Populations ( 8.2 )]. ● Advise patients that use of tetracycline class drugs orally during tooth development (infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). ● Advise patients that use of doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during infancy and childhood. ● Advise patients that pseudomembranous colitis can occur with doxycycline therapy.

If patients develop watery or bloody stools, they should seek medical attention. ● Advise patients that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention. ● Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline.

If patients need to be outdoors while using doxycycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of sunburn. ● Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. Symptoms may be manifested by arthralgia, fever, rash and malaise.

Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help. ● Counsel patients about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy. ● Advise patients to take doxycycline capsules exactly as directed. Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 09/2025 205966-02

💬 Medication Guide ~3 min read ▾

PATIENT INFORMATION Doxycycline Capsules (doks i SYE kleen) Read this Patient Information before you start taking doxycycline capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What are doxycycline capsules? Doxycycline capsules are a tetracycline-class medicine. Doxycycline capsules are a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea.

Doxycycline capsules do not lessen redness caused by rosacea. Doxycycline capsules should not be used for the treatment or prevention of infections. It is not known if doxycycline capsules are: ● effective for use for longer than 16 weeks. ● safe for use longer than 9 months. ● safe and effective in children.

Doxycycline capsules should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children. Who should not take doxycycline capsules? Do not take doxycycline capsules if you are allergic to doxycycline or other medicines in the tetracycline-class.

Ask your doctor or pharmacist for a list of these medicines if you are not sure. What should I tell my doctor before taking doxycycline capsules? Before you take doxycycline capsules tell your doctor if you: ● have kidney problems. ● have liver problems. ● have diarrhea or watery stools. ● have vision problems. ● have had surgery on your stomach (gastric surgery). ● have or had a yeast or fungal infection in your mouth or vagina. ● have any other medical condition. ● are pregnant or plan to become pregnant.

Doxycycline capsules may harm your unborn baby. Taking doxycycline capsules while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking doxycycline capsules and call your doctor right away if you become pregnant while taking doxycycline capsules. ● are breastfeeding or plan to breastfeed.

Doxycycline can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take doxycycline capsules. You and your doctor should decide if you will take doxycycline capsules or breastfeed.

You should not do both. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Doxycycline capsules and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take: ● a blood thinner medicine. ● a penicillin (antibacterial medicine). ● proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium. ● products containing iron or bismuth subsalicylate. ● a medicine taken by mouth that contains isotretinoin or acitretin. ● a medicine to treat seizures, such as carbamazepine or phenytoin. Ask your doctor or pharmacist for a full list of these medicines, if you are not sure. Know the medicines you take.

Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take doxycycline capsules? ● Take doxycycline capsules exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to doxycycline capsules. ● Take doxycycline capsules 1 time a day in the morning on an empty stomach. ● You should take doxycycline capsules at least one hour before or two hours after a meal. ● Take doxycycline capsules with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus.

Your esophagus is the tube that connects your mouth to your stomach. ● If you took too many doxycycline capsules call your doctor right away. ● Your doctor may do blood tests during treatment with doxycycline capsules to check for side effects. What should I avoid while taking doxycyc… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Doxycycline capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline capsules were investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for doxycycline capsules following single oral doses and at steady-state in healthy subjects are presented in Table 2.

Table 2. Pharmacokinetic Parameters [Mean (±SD)] for Doxycycline Capsules N Cmax* (ng/mL) Tmax + (hr) AUC 0-oo * (ng•hr/mL) t 1/2 * (hr) Single Dose 40 mg capsules 30 510 ± 220.7 3.00 (1.0-4.1) 9227± 3212.8 21.2 ±

7.6Steady-State# 40 mg capsules 31 600 ± 194.2 2.00 (1.0-4.0) 7543 ± 2443.9 23.2 ± 6.2 *Mean + Median # Day 7 Absorption: In a single-dose food-effect study involving administration of doxycycline capsules to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption (C max and AUC) by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if doxycycline capsules are taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.

Distribution: Doxycycline is greater than 90% bound to plasma proteins. Metabolism: Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

Excretion: Doxycycline is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of doxycycline capsules.

Special Populations Geriatric: Doxycycline pharmacokinetics have not been evaluated in geriatric patients. Pediatric: Doxycycline pharmacokinetics have not been evaluated in pediatric patients [ see Warnings and Precautions ( 5.1 ) ]. Gender: The pharmacokinetics of doxycycline capsules were compared in 16 male and 14 female subjects under fed and fasted conditions.

While female subjects had a higher C max and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass. Race: Differences in doxycycline pharmacokinetics among racial groups have not been evaluated. Renal Insufficiency: Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function.

Hemodialysis does not alter the serum half-life of doxycycline. Hepatic Insufficiency: Doxycycline pharmacokinetics have not been evaluated in patients with hepatic insufficiency. Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of doxycycline is reported to be reduced at high pH.

This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric. Drug Interactions: [ see Drug Interactions ( 7 ) ].

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The safety and efficacy of doxycycline capsules in the treatment of only inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebocontrolled, multi-centered, double-blind, 16-week Phase 3 trials involving 537 subjects (total of 269 subjects on doxycycline capsules from the two trials) with rosacea (10 to 40 papules and pustules and two or fewer nodules). Mean baseline lesion counts were 20 and 21 for doxycycline capsules and placebo subject groups respectively.

Pregnant and nursing women, subjects <18 years of age, and subjects with ocular rosacea and/or blepharitis/meibomianitis who require ophthalmologic treatment were excluded from trials. At Week 16, subjects in the doxycycline capsules group were evaluated using co-primary endpoints of mean reduction in lesion counts and a dichotomized static Investigator’s Global Assessment of Clear or Almost Clear (defined as 1 to 2 small papules or pustules) when compared to the placebo group in both Phase 3 trials. Table 3: Clinical Results of Doxycycline Capsules versus Placebo Study 1 Study 2 Doxycycline Capsules Placebo Doxycycline Capsules Placebo 40 mg N=127 N=124 40 mg N=142 N=144 Mean Change in Lesion Count from Baseline -11.8 -5.9 -9.5 -4.3 No.

(%) of Subjects Clear or Almost Clear in the IGA* 39 (30.7%) 24 (19.4%) 21 (14.8%) 9 (6.3%) *Investigator’s Global Assessment Subjects treated with doxycycline capsules did not demonstrate significant improvement in erythema when compared to those treated with placebo.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY Click here to enter Nonclinical Toxicology

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use doxycycline capsules [exposure comparison based upon area under the curve (AUC) values].

No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycycline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses.

Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of doxycycline capsules when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline capsules on human fertility is unknown.

13.2Animal Toxicology and/or Pharmacology Click here to enter Animal Toxicology and/or Pharmacology

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Doxycycline was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately 12.2 times that observed in female humans who use doxycycline capsules [exposure comparison based upon area under the curve (AUC) values].

No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied. Doxycycline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.

Doxycycline demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that doxycycline is a weak clastogen. Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses.

Doxycycline induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of doxycycline contained in the recommended daily dose of doxycycline capsules when compared on the basis of AUC estimates. Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of doxycycline capsules on human fertility is unknown.

📚 References 7 words ▾

15 REFERENCES Click here to enter References

📄 Package Label / Principal Display Panel 108 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Doxycycline Capsules 40 mg NDC 43547-590-03 *Each capsule contains: *30 mg immediate release and 10 mg delayed-release beads equivalent to 40 mg anhydrous doxycycline, USP. INERT INGREDIENTS: See prescribing information. USUAL DOSAGE: ONE CAPSULE PER DAY.

This package is child-resistant. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispensed in tight, light-resistant containers.

Print Patient Information at: www.solcohealthcare.com/druglabeling/doxycycline-capsules.pdf Keep out of reach of children. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Rev.: 09/2025 205965-02 40mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43547-0567-10 · Solco 43547-0595-10 · SOLCO →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.