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Stonarhini
chlorpheniramine maleate, phenylephrine · Stonarhini is an over-the-counter drug containing chlorpheniramine maleate, phenylephrine, made by Sato Pharmaceutical Co., Ltd..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 1
Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis). ■ sneezing ■ runny nose ■ itchy, watery eyes ■ nasal congestion, stuffy nose ■ itchy throat
Drug facts
- Generic name
- chlorpheniramine maleate, phenylephrine
- Active ingredients
- Chlorpheniramine Maleate, Phenylephrine Hydrochloride
- Dosage forms
- Tablet
- Label holder
- Sato Pharmaceutical Co., Ltd.
- FDA application
- M012
- Label updated
- 07/31/2026
Active ingredients
(In each tablet) Chlorpheniramine Maleate 2 mg Phenylephrine HCl 5 mg
Purpose
Chlorpheniramine Maleate Antihistamine Phenylephrine HCl Nasal decongestant
Uses
Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
- Sneezing
- Runny nose
- Itchy, watery eyes
- Nasal congestion, stuffy nose
- Itchy throat
Directions
Adults and children 12 years and over: 2 tablets every 4 hours, not to exceed 12 tablets in 24 hours children under 12 years of age: ask a doctor
Warnings
Enter section text here Do not use this product
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this priduct. Ask a doctor before use if you have
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Difficulty in urination due to enlargement of the prostate Ask a doctor or pharmacist before use
- If you are taking sedatives or tranquilizers When using this product
- Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
- You may get drowsy.
- May cause excitability, especially in children.
- Alcohol, sedatives and tranquilizers may increase the drowsiness effect.
- Avoid alcoholic beverages.
- Use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if
- Symptoms do not improve within seven days
- Symptoms are accompanied by fever
Do not use
This product
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this priduct.
Ask a doctor before use
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
- Heart disease
- Thyroid disease
- Diabetes
- High blood pressure
- Difficulty in urination due to enlargement of the prostate
Ask a doctor or pharmacist before use
- If you are taking sedatives or tranquilizers
When using this product
- Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
- You may get drowsy.
- May cause excitability, especially in children.
- Alcohol, sedatives and tranquilizers may increase the drowsiness effect.
- Avoid alcoholic beverages.
- Use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor
- Symptoms do not improve within seven days
- Symptoms are accompanied by fever
Pregnancy or breastfeeding
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. Prompt attention is critical even if you do not notice any signs or symptoms.
Inactive ingredients
Aspartame, colloidal silicone dioxide, FD&C Red No. 40 aluminum Lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 2 mg / 5 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- Sato Pharmaceutical Co., Ltd.Shown hereM012 · Label 07/31/2026 · NDC 49873-109Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing05/06/2026Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03Wells Pharma of Houston LLC · cGMP deviations.
- Class IIDrugOngoing12/17/2025Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL...Fagron Compounding Services · Incorrect Product Formulation
- Class IIDrugOngoing12/10/2025Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave...Park Avenue Compounding · CGMP Deviations
- Class IIIDrug07/30/2025Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL...Imprimis NJOF, LLC · Sub-Potent Drug: Subpotent assay results during stability testing.
- Class IIDrugOngoing04/30/2025PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only...Denver Solutions, LLC DBA Leiters Health · Lack of Assurance of Sterility: Leaking/damaged syringes.
Stonarhini: common questions
- What is Stonarhini used for?
- Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis). ■ sneezing ■ runny nose ■ itchy, watery eyes ■ nasal congestion, stuffy nose ■ itchy throat
- Is Stonarhini a prescription drug?
- No. Stonarhini is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Stonarhini?
- Yes. Other FDA-listed products with the same active ingredients include Giltuss D, Phenagil, Actidom Da, Broncochem Allergy Control.
- Who makes Stonarhini?
- Sato Pharmaceutical Co., Ltd. lists Stonarhini with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/31/2026 · Label text is shown as published by the manufacturer. Not medical advice