Label: DURAFLU- acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
- NDC Code(s): 50991-535-01, 50991-535-02
- Packager: Poly Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 27, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Temporarily relieves
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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)
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
- More than 3,000 mg of acetaminophen in 24 hrs;
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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.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DURAFLU
acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-535 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 20mm Flavor Imprint Code PE;723 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50991-535-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2015 2 NDC:50991-535-02 6 in 1 CARTON 10/01/2015 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2015 Labeler - Poly Pharmaceuticals, Inc. (198449894)
