Quick answers
- What is Acetaminophen, dextromethorphan, guaifenesin and pseudoephedrine used for?
- The Drug Facts label of Duraflu (Poly Pharmaceuticals, Inc.) lists these uses: Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold.
- Do I need a prescription for Acetaminophen, dextromethorphan, guaifenesin and pseudoephedrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Acetaminophen, dextromethorphan, guaifenesin and pseudoephedrine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Duraflu · Poly Pharmaceuticals, Inc.
Acetaminophen 325 mg · Dextromethorphan hydrobromide 20 mg · Guaifenesin 200 mg · Pseudoephedrine hydrochloride 60 mg, tablet (oral)
Active ingredient
Acetaminophen 325 mg Dextromethorphan HBr 20 mg Guaifenesin 200 mg Pseudoephedrine HCl 60 mg
Purpose
Pain Reliever Antitussive Expectorant Nasal Decongestant
Uses
Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 3,000 mg of acetaminophen in 24 hrs; with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not Exceed recommended dosage
- KEEP THIS AND ALL MEDICATION
- OUT OF REACH OF CHILDREN Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Do not use
this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever 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
Ask a doctor before use if
you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating
- due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin.
When using this product
do not exceed recommended dosage.
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition
Directions
| Adults and children 12 years of age and over: | 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctor |
| Children under 12 years of age | ½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor |
When using this product do not exceed recommended dosage.
Inactive ingredients
magnesium stearate, microcrystalline cellulose, stearic acid
Questions?
800-882-1041 Manufactured For: Poly Pharmaceuticals, Inc. Huntsville, AL 35763 Rev. 08/15
— FDA label of Duraflu, Poly Pharmaceuticals, Inc., effective November 9, 2024. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Acetaminophen 325 mg · Dextromethorphan hydrobromide 20 mg · Guaifenesin 200 mg · Pseudoephedrine hydrochloride 60 mg · tablet (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Duraflu | Poly Pharmaceuticals, Inc. | DailyMed |
Acetaminophen 325 mg · Dextromethorphan hydrobromide 10 mg · Guaifenesin 200 mg · Pseudoephedrine hydrochloride 30 mg · capsule, liquid filled (oral) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Vicks DayQuil-D COLD and SINUS plus SEVERE CONGESTION | The Procter & Gamble Manufacturing Company | — |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Poly Pharmaceuticals, Inc.1 product
- The Procter & Gamble Manufacturing Company1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youA pharmacist can answer questions about this label
- Latest FDA drug recallsPrescription and over-the-counter, newest first
- All over-the-counter medicinesSearch by ingredient, brand or Spanish name
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.