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Cosedal Drops
dextromethorphan hbr, guaifenesin · Cosedal Drops is an expectorant (over-the-counter) containing dextromethorphan hbr, guaifenesin, made by Menper Distributors, Inc..
- Type
- Over the counter
- Drug class
- Expectorant
- Route
- Oral
- Manufacturers
- 1
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Drug facts
- Generic name
- dextromethorphan hbr, guaifenesin
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin
- Drug class
- Expectorant
- Dosage forms
- Liquid
- Label holder
- Menper Distributors, Inc.
- FDA application
- M012
- Label updated
- 07/22/2025
Active ingredients
Dextromethorphan HBR Guaifenesin
Purpose
Cough Suppressant Expectorant
Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Directions
Do not exceed 6 doses in 24 hours. age dose 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours Children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) every 4 hours Children under 2 years of age consult your doctor
Warnings
Do not exceed recommended dosage. A persistent cough may be a sign of a serious condition. If cough persists more than one week, tends to reoccur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not use
This product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. 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.
Pregnancy or breastfeeding
If you are pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
Keep out of reach of children.
Inactive ingredients
Citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben, raspberry falvor, sucrose, water
Questions?
Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Liquid | 10 mg/5mL / 100 mg/5mL | oral | 1 |
Manufacturers and labels
1 FDA label
- Menper Distributors, Inc.Shown hereM012 · Label 07/22/2025 · NDC 53145-059Full label
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...
Cosedal Drops: common questions
- What is Cosedal Drops used for?
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
- Is Cosedal Drops a prescription drug?
- No. Cosedal Drops is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Cosedal Drops?
- Yes. Other FDA-listed products with the same active ingredients include Guaifenesin and Dextromethorphan Hbr, Mucus Relief DM, Mucus Relief DM Extended Release Caplets, Mucus Relief Dm.
- Who makes Cosedal Drops?
- Menper Distributors, Inc. lists Cosedal Drops with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/22/2025 · Label text is shown as published by the manufacturer. Not medical advice