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sinus
pseudoephedrine hydrochloride · sinus is an over-the-counter drug containing pseudoephedrine hydrochloride, made by Kroger Company.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 1
• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IDrugOngoing06/17/2026BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30...BEEKEEPER'S NATURALS USA INC. · Microbial Contamination of Non-Sterile Products
- Class IIDrugOngoing01/21/2026TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM...GOLD STAR DISTRIBUTION INC · CGMP Deviations: Insanitary conditions including rodent...
- Class IDrug11/01/2023ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VABiomic Sciences, LLC dba ION Intelligence of Nature · 3 products · Microbial contamination of Non-Sterile Products
- Class IIDrugOngoing03/15/2023NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. (24ml), Mfd. for Healthway Corp....Nutraceutical Corporation · CGMP Deviations: Raw material recalled by repackager, due to...
- Class IIIDrug01/25/2023SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555...Intersect ENT, Inc. · Failed Dissolution Specification; product did not meet the average...
Active ingredients
(in each tablet) Pseudoephedrine HCl 30 mg
Purpose
Nasal decongestant
Uses
- Temporarily relieves sinus congestion and pressure
- Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Directions
Adults and children 12 years and over
- Take 2 tablets every 4 to 6 hours
- Do not take more than 8 tablets in 24 hours children ages 6 to 11 years
- Take 1 tablet every 4 to 6 hours
- Do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age
Warnings
Do not use 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if
- Nervousness, dizziness, or sleeplessness occur
- Symptoms do not improve within 7 days or occur with a fever 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 (1-800-222-1222).
Do not use
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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland
When using this product
Do not exceed recommended dosage
Stop use and ask a doctor
- Nervousness, dizziness, or sleeplessness occur
- Symptoms do not improve within 7 days or occur with a 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 (1-800-222-1222).
Other information
- Each tablet contains: calcium 20 mg
- Store at 20 ° -25 ° C (68 ° -77 ° F)
- Do not use if blister unit is broken or torn
Inactive ingredients
Carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide
Questions?
1-800-632-6900
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, film coated | 30 mg | oral | 1 |
Manufacturers and labels
1 FDA label
- Kroger CompanyShown hereM012 · Label 09/20/2024 · NDC 30142-613Full label
sinus: common questions
- What is sinus used for?
- • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- Is sinus a prescription drug?
- No. sinus is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as sinus?
- Yes. Other FDA-listed products with the same active ingredients include Pseudoephedrine Hydrochloride, Nasal Decongestant, Nasal Decongestant Maximum Strength, Pseudoephedrine Hcl.
- Who makes sinus?
- Kroger Company lists sinus with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 09/20/2024 · Label text is shown as published by the manufacturer. Not medical advice