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Actinel
dextromethorphan hbr,guaifenesin,pseudoephedrine hcl · Actinel is an expectorant (over-the-counter) containing dextromethorphan hbr,guaifenesin,pseudoephedrine hcl, made by ACTIPHARMA, LLC.
- Type
- Over the counter
- Drug class
- Expectorant
- Route
- Oral
- Manufacturers
- 1
• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive •...
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrug02/12/2025Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI...PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Superpotent; sodium benzoate preservative
- Class IIDrug12/18/2024Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg...LNK International, Inc. · CGMP Deviations: Released product should have been rejected.
- Class IIDrug11/27/2024Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite...The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 2 products · Failed Impurity/Degradation Specifications
- Class IIIDrugOngoing11/13/2024Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz...Denison Pharmaceuticals, LLC · 2 products · Crystallization: Lack of uniformity - a change in texture, chunky...
- Class IIDrugOngoing03/20/2024Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL...Global Corporation · Stability testing failures for one or two of the four active...
Active ingredients
(in each 5 mL tsp) Dextromethorphan HBr, 15 mg Guaifenesin, 200 mg Pseudoephedrine HCl, 30 mg
Purpose
Cough Suppressant Expectorant Nasal Decongestant
Uses
- Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
- Helps control the cough reflex that causes coughing
- Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
- Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
Directions
- Do not take more than 4 doses in any 24-hour period. AGE DOSE Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours Children under 12 years of age do not use
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
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. Stop use and ask a doctor if
- You get nervous, dizzy, or sleepless
- Symptoms do not get better within 7 days or are accompanied by fever
- Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. 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.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Other information
- Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened
- Store at controlled room temperature 15°- 30°C (59° - 86°F)
- Avoid excessive heat or humidity.
Inactive ingredients
Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose
Questions?
Call weekdays from 8AM to 4PM AST at 1.787.608.0882
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Solution | 15 mg/5mL / 200 mg/5mL / 30 mg/5mL | oral | 1 |
Manufacturers and labels
1 FDA label
- ACTIPHARMA, LLCShown hereM012 · Label 07/08/2025 · NDC 63102-101Full label
Actinel: common questions
- What is Actinel used for?
- • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive •...
- Is Actinel a prescription drug?
- No. Actinel is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Actinel?
- Yes. Other FDA-listed products with the same active ingredients include Actinel Pediatric, Actispec Pse, Capmist DM, Poly-Vent DM.
- Who makes Actinel?
- ACTIPHARMA, LLC lists Actinel with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/08/2025 · Label text is shown as published by the manufacturer. Not medical advice