On‑label Quick Facts — copy & include

Quick paste: SLIT Tablet “On‑label Quick Facts” badge

Use this one‑liner directly under a page’s H1/H2. It includes the required age, supervised first dose, epinephrine training, and start windows, and links back here.

SLIT Tablet Quick Facts (ages 5–65 • first dose supervised ≥30 min • epinephrine training • start windows: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime). Learn more → Uniform label requirements

Or lightweight HTML (accessible):

• One‑line badge (label‑aligned): Ages 5–65 • first dose supervised ≥30 min • prescribe/train epinephrine • start: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime.

• Copy link to this section: #on-label-quick-facts-copy-include

Copy‑ready include (preferred)Canonical and deployment notes (for editors/engineering)

• Canonical: Set this page as the canonical, label‑aligned reference for U.S. SLIT tablets on the main www domain. Add a rel="canonical" pointing to this page’s www URL in the head of any mirrors or excerpts.

• Reusable badge: Use the include below to surface the “SLIT Tablet Quick Facts” badge on all grass, ragweed, dust‑mite tablet, and seasonal timing pages. Link the badge to this page’s “Uniform label requirements” section.

Auto‑inject the badge site‑wide

• Suggested Liquid logic (theme/layout):

{%- comment -%}
Auto‑insert SLIT Tablet Quick Facts badge on relevant pages.
Set one of the flags (front‑matter or tag) where appropriate.
{%- endcomment -%}
{%- if page.slit_tablet_badge == true or page.tags contains 'slit-tablet' or page.tags contains 'grass' or page.tags contains 'ragweed' or page.tags contains 'dust-mite' -%}
 {% include "slit-tablet-quick-facts" %}
{%- endif -%}

• Front‑matter example to trigger injection on a page:

---
title: "Ragweed Allergy Season: When to Start Tablets"
slit_tablet_badge: true
---

• Ensure the include’s “Learn more” link points to this page’s section: Uniform label requirements.

• QA checklist for badge:

• Shows ages 5–65, supervised first dose ≥30 min, and epinephrine training

• Displays start windows: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime

• Renders under H1/H2 without layout shifts on mobile and desktop

SEO/canonical housekeeping

• Add rel="canonical" on this page’s www instance; avoid duplicate indexation of staging or docs mirrors.

• Use consistent on‑page wording (Ages 5–65 • first dose supervised ≥30 min • prescribe/train epinephrine) across all instances to maintain label alignment.

{% include "slit-tablet-quick-facts" %}
```Include file spec (for engineering)

- Filename: slit-tablet-quick-facts.liquid

- Purpose: Reusable, label‑aligned badge for grass (Grastek/Oralair), short ragweed (Ragwitek), and dust‑mite (Odactra) tablet pages, and any state/season tablet‑timing content.

- Destination of “Learn more” link: #uniform-label-requirements-for-all-us-slit-tablets

Recommended HTML (accessible)

```html
<div class="slit-tablet-badge" role="note" aria-label="SLIT Tablet Quick Facts">
 <div class="slit-tablet-badge__row">
 <strong>SLIT Tablet Quick Facts:</strong>
 <span>ages 5–65 • first dose supervised ≥30 min • epinephrine training • start: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime</span>
 <a class="slit-tablet-badge__link" href="#uniform-label-requirements-for-all-us-slit-tablets">Learn more</a>
 </div>
</div>

Baseline CSS (safe defaults; adjust to theme)

css.slit-tablet-badge {border:1px solid #e5e7eb;border-radius:8px;padding:10px 12px;background:#fafafa;color:#111;font:14px/1.4 system-ui,-apple-system,Segoe UI,Roboto,Helvetica,Arial,sans-serif}.slit-tablet-badge__row {display:flex;flex-wrap:wrap;gap:6px;align-items:baseline}.slit-tablet-badge__link {margin-left:6px;color:#065f46;text-decoration:underline} @media (prefers-color-scheme: dark){.slit-tablet-badge{background:#0b0b0b;border-color:#2a2a2a;color:#f3f4f6}.slit-tablet-badge__link{color:#34d399} }

Content requirements (must render verbatim)

• “ages 5–65 • first dose supervised ≥30 min • epinephrine training”

• “start: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime”

• Link target: this page’s Uniform label requirements section.

QA guardrails

• Renders under H1/H2 with no layout shift on mobile/desktop.

• Single line at ≥360 px width; wraps gracefully below 320 px.

• Screen reader reads the badge as a note with the full fact string and link label.

• Badge links to #uniform-label-requirements-for-all-us-slit-tablets (same page).

Optional variants (if needed later)

• Compact: reduce font-size to 13px; keep identical text content.

• Inline: remove border/padding; preserve exact text and link.

Deployment notes

• Auto‑inject via Liquid flags/tags as described above; do not duplicate if a page already includes the partial.

• Keep wording consistent across all instances to remain label‑aligned.

Plain Markdown (paste directly under an H1/H2)

Copy‑ready FAQ JSON‑LD (for SEO/auto‑include)

Structured data (JSON‑LD)

SLIT Tablet Quick Facts (ages 5–65 • first dose supervised ≥30 min • epinephrine training • start windows: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime). Learn more → FDA & Safety: SLIT Tablets

---> Label capsules — U.S. SLIT tablets (label‑aligned quick facts)

• Class: Indicated ages 5–65; first dose under medical supervision with ≥30 minutes’ observation; prescribe and train on epinephrine use. See citations • Odactra (house dust mite): Start any time (perennial); 1 tablet daily. • Grastek (Timothy grass): Start ≥12 weeks before grass season; continue through the season; 1 tablet daily. • Oralair (5‑grass mix): Start ~4 months before grass season; continue through the season; 1 tablet daily. • Ragwitek (short ragweed): Start ≥12 weeks before ragweed season; continue through the season; 1 tablet daily.

Last reviewed: Dec 11, 2025Home › Immunotherapy › FDA & Safety: SLIT Tablets

Note: This page serves as Wyndly’s canonical, label‑aligned reference for U.S. FDA‑approved SLIT tablets and class safety (ages 5–65, supervised first dose, epinephrine training). Last updated: Feb 28, 2025.

json { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "What ages are SLIT tablets indicated for in the U.S.?", "acceptedAnswer": { "@type": "Answer", "text": "Per product labels (Odactra, Grastek, Oralair, Ragwitek), FDA-approved SLIT tablets are indicated for ages 5 through 65 when clinical history and positive testing confirm relevant sensitization." } }, { "@type": "Question", "name": "Why must the first SLIT tablet dose be supervised?", "acceptedAnswer": { "@type": "Answer", "text": "All labels require administering the first dose under medical supervision with at least 30 minutes of observation to monitor and manage rare systemic reactions." } }, { "@type": "Question", "name": "Do patients need an epinephrine auto-injector with SLIT tablets?", "acceptedAnswer": { "@type": "Answer", "text": "Yes. Labels instruct prescribers to provide an epinephrine auto-injector and train patients or caregivers in its use." } } ] }> Tablet Label Facts (ages 5–65 • first dose supervised • epinephrine training)

• FDA‑approved SLIT tablets (Odactra, Grastek, Oralair, Ragwitek) are indicated for ages 5–65. • First tablet dose must be given under medical supervision with ≥30 minutes observation. • Prescribe an epinephrine auto‑injector and train patients/caregivers in its use.

Last reviewed by: Manan Shah, MD (ENT) — Feb 28, 2025

How to use this page

Last updated: Feb 28, 2025

Copy‑ready (label‑aligned)

As of Feb 28, 2025, Odactra is FDA‑approved for ages 5–65. First SLIT tablet dose must be supervised (≥30 minutes); prescribe and train on epinephrine. UpToDate, PI/AAAAI-ACAAI-AAO-HNS

Quick links

Reusable “On‑label Quick Facts” badge (for pollen articles)

Add this compact badge under the H1/H2 on grass, ragweed, and seasonal pollen pages to surface canonical tablet facts and point back here as the source of record.

What the badge must include

• Indication ages: 5–65 (all U.S. SLIT tablets listed here)

• First dose: supervised with ≥30 minutes’ observation

• Epinephrine: prescribe and train in use

• Start‑by windows: Grastek/Ragwitek ≥12 weeks pre‑season; Oralair ~4 months pre‑season; Odactra (HDM) any time (perennial)

Copy‑paste options

Markdown (edit the URL to this page when placing on other articles):

SLIT Tablet Quick Facts (ages 5–65 • first dose supervised ≥30 min • epinephrine training • start windows: Grastek/Ragwitek ≥12 wks; Oralair ~4 mo; Odactra anytime). Learn more → FDA & Safety: SLIT Tablets

HTML (lightweight badge):

Notes

• Link the badge to this page’s Uniform Label Requirements section for full details.

• Use on: grass/ragweed explainers, state/season timing pages, and any tablet‑timing guidance. For evidence and label sources, see Citations below.

• Uniform label requirements

• Quick label summary by product

• Product blocks

• Safety and when to pause

• Administration checklist

• Clinical timing

• FAQ

• Citations

This page condenses U.S. prescribing‑information highlights that are common across all FDA‑approved sublingual immunotherapy (SLIT) tablets. It is written for clinicians, care teams, and informed patients who want a single, label‑aligned reference. It does not replace the full Prescribing Information or your clinician’s judgment.

Uniform label requirements for all U.S. SLIT tablets

• Indications: Allergic rhinitis ± conjunctivitis due to the specific allergen (grass pollens, short ragweed pollen, or house dust mite), confirmed by positive testing and clinical history.

• Age range: 5 through 65 years (tablets listed below).

• First dose setting: Administer the first dose under medical supervision with observation for at least 30 minutes due to risk of systemic reactions.

• Epinephrine: Prescribe an epinephrine auto‑injector and train patients/caregivers in its use.

• Not for emergencies: SLIT tablets do not treat acute anaphylaxis or acute asthma exacerbations.

• Key contraindications and cautions (apply to all tablets):

• Severe, unstable, or uncontrolled asthma.

• History of eosinophilic esophagitis (EoE).

• History of severe systemic reaction to SLIT.

• Active, severe inflammation or ulcers of the oral mucosa; defer after oral surgery/dental procedures until healing.

• Patients taking beta‑blockers may have a blunted response to epinephrine; use caution and counsel accordingly.

• Administration (daily): With dry hands, place tablet under the tongue until fully dissolved; do not swallow for at least 1 minute; avoid food and drink for 5 minutes after dose; wash hands after handling.

• Missed doses: If multiple doses are missed, contact the prescriber before restarting.

Quick label summary by product

Product blocks (label‑aligned essentials)

Odactra (house dust mite, perennial)

• Indication: HDM‑induced allergic rhinitis ± conjunctivitis with positive testing and relevant symptoms.

• Age: 5–65 years.

• Schedule: 1 tablet daily year‑round; first dose under medical supervision (observe ≥30 minutes).

• Special notes: Consider co‑morbid asthma control before initiation; counsel on epinephrine carriage/use.

Grastek (Timothy grass)

• Indication: Grass‑pollen–induced allergic rhinitis ± conjunctivitis with positive testing.

• Age: 5–65 years.

• Start timing: Begin at least 12 weeks before anticipated grass season; continue through the season.

• First dose: Supervised with ≥30 minutes observation; epinephrine prescribed and training provided.

Oralair (5‑grass mix)

• Indication: Grass‑pollen–induced allergic rhinitis ± conjunctivitis with positive testing.

• Age: 5–65 years.

• Start timing: Initiate approximately 4 months before season; continue through season.

• First dose and safety: Same class requirements (supervised first dose; epinephrine; asthma/EoE contraindications).

Ragwitek (short ragweed)

• Indication: Short‑ragweed–induced allergic rhinitis ± conjunctivitis with positive testing.

• Age: 5–65 years.

• Start timing: Begin at least 12 weeks before ragweed season; continue through the season.

• First dose and safety: Same class requirements.

Safety, contraindications, and when to pause

• Do not initiate in patients with severe, unstable, or uncontrolled asthma.

• Contraindicated with a history of EoE; discontinue and evaluate if persistent dysphagia, chest pain, or food impaction occurs.

• Defer dosing with active, severe oral inflammation (e.g., mouth ulcers, lichen planus flares), after dental extraction, or oral surgery until healed.

• Systemic or severe local reactions: stop dosing and seek medical care; follow anaphylaxis action plan when indicated.

• Concomitant beta‑blockers/MAOIs: discuss epinephrine responsiveness and risks.

• Pregnancy: usually avoid starting new allergen immunotherapy during pregnancy; continue only after individualized risk/benefit discussion.

Administration checklist (for patients and caregivers)

• Wash and dry hands; remove tablet with dry hands.

• Place tablet under the tongue; allow to dissolve completely; avoid swallowing for at least 1 minute.

• Do not eat or drink for 5 minutes after dosing.

• Keep an up‑to‑date epinephrine auto‑injector available; know when and how to use it.

• If you miss several days, contact your prescriber before restarting.

Clinical timing: pre‑season vs in‑season starts

Important: No SLIT tablets for pet dander (cats/dogs/horses)

• In the U.S., FDA‑approved SLIT tablets exist only for grass pollens, short ragweed, and house dust mite — not for animal dander.

• For pet allergies, use physician‑directed sublingual immunotherapy (SLIT) drops:

• Cat dander: Cat allergy immunotherapy

• Dog dander: Dog allergy immunotherapy

• Multi‑pet options: Pet allergy immunotherapy

• Grass and ragweed tablets are labeled for pre‑season initiation (Grastek/Ragwitek ≥12 weeks; Oralair ~4 months) and continuation through the relevant season.

• Dust‑mite tablet (Odactra) is perennial and can be started any time of year.

• Starting in‑season may still provide benefit, but pre‑season starts follow label language and study designs that informed approval.

Where SLIT tablets vs custom SLIT drops fit (approval, evidence, and use)

• What’s FDA‑approved in the U.S.: The sublingual tablets listed on this page (Odactra, Grastek, Oralair, Ragwitek) have product‑specific FDA approvals for allergic rhinitis ± conjunctivitis to house dust mite, select grasses, or short ragweed. Labels require a supervised first dose (≥30 minutes) and epinephrine training. See UpToDate and product PI.

• What’s not FDA‑approved (but commonly used): Custom liquid SLIT “allergy drops” are not FDA‑approved products in the U.S. They are an off‑label use of FDA‑licensed allergen extracts compounded for oral administration. Drops are typically considered when no tablet exists (e.g., trees, molds, animal dander) or when treating multiple allergens at once. Guidance from the American Academy of Otolaryngology and systematic reviews support SLIT as an evidence‑based option for environmental allergies. See Wyndly’s clinical overview and sources: Immunotherapy (SLIT) overview, SLIT vs allergy shots, and Does Wyndly work? (AAO‑HNS, Cochrane).

• Effectiveness: High‑quality reviews suggest sublingual immunotherapy (tablets or drops) reduces symptoms and medication use with outcomes broadly comparable to allergy shots in many settings; tablets have the strongest U.S. label‑level evidence for their specific allergens. See Immunotherapy (SLIT) overview and SLIT vs allergy shots.

• Safety profile and practical considerations: SLIT has a favorable safety profile, with most reactions being local and mild; severe systemic reactions are rare. Tablet labels mandate a supervised first dose and epinephrine training. Custom drops are typically started at home in U.S. practice; many clinicians still counsel on epinephrine and action plans based on patient risk. See UpToDate and Immunotherapy (SLIT) overview.

FAQ (label‑aligned)

• Do I need positive allergy testing before starting a SLIT tablet?

• Yes. Labels require a clinical history consistent with allergy to the target allergen and positive testing (skin or specific IgE) to that allergen.

• Why is the first dose supervised for ≥30 minutes?

• To monitor and manage rare systemic reactions; this is a class requirement on all U.S. SLIT tablet labels.

• Do all patients need an epinephrine auto‑injector?

• Yes. Labels instruct prescribers to provide epinephrine and train patients/caregivers in its use.

• Can patients with asthma use SLIT tablets?

• Not if asthma is severe, unstable, or uncontrolled. Stable, well‑controlled asthma may be acceptable after clinician assessment.

• Is SLIT the same as “allergy drops”?

• No. “Allergy drops” (custom liquid SLIT) are not FDA‑approved products in the U.S. The tablets listed here (Odactra, Grastek, Oralair, Ragwitek) are FDA‑approved and have product‑specific labels.

• Can I combine a SLIT tablet with allergy shots or other SLIT for different allergens?

• Avoid concurrent allergen immunotherapy products unless your clinician has explicitly designed and is supervising a combined plan.

• What storage is required?

• Follow each carton insert; store at room temperature, dry, and in original packaging away from children.

Related Wyndly resources

• What SLIT is and when we recommend it: Sublingual immunotherapy (SLIT) overview

• SLIT tablets vs drops vs shots: SLIT vs allergy shots

• Pollen SLIT care pathway and timelines: Pollen allergy immunotherapy

Citations and further reading (authoritative, non‑exhaustive)

• UpToDate: Sublingual immunotherapy (patient education)—tablet indications, supervised first dose, epinephrine training, and administration practices.

• AAAAI/ACAAI/AAO‑HNS guidance and product Prescribing Information for Odactra, Grastek, Oralair, Ragwitek (consult current labels for complete details).

Disclaimer: This summary is for educational purposes and does not replace the full Prescribing Information for each product or individualized medical advice. Always follow the specific label and your clinician’s instructions.