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NDC 50991-0535-02 Duraflu 325; 20; 200; 60 mg/1; mg/1; mg/1; mg/1 Details

Duraflu 325; 20; 200; 60 mg/1; mg/1; mg/1; mg/1

Duraflu is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Poly Pharmaceuticals, Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 50991-0535-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 50991-0535-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 50991-0535-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 50991-0535-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	50991-0535
Product ID	50991-535_f4c84047-fd3f-ea66-e053-2a95a90ae9aa
Associated GPIs	43998304200335
GCN Sequence Number	075065
GCN Sequence Number Description	pseudoeph/DM/guaifen/acetamin TABLET 60-20-325 ORAL
HIC3	B4P
HIC3 Description	NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT
GCN	39986
HICL Sequence Number	035285
HICL Sequence Number Description	PSEUDOEPHEDRINE/DEXTROMETHORPHAN/GUAIFENESIN/ACETAMINOPHEN
Brand/Generic	Brand
Proprietary Name	Duraflu
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325; 20; 200; 60
Active Ingredient Units	mg/1; mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Poly Pharmaceuticals, Inc.
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

NDC 50991-0535-02 (50991053502)

Pricing Information	N/A
NDC Package Code	50991-535-02
Billing NDC	50991053502
Package	6 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK
Marketing Start Date	2015-10-01
NDC Exclude Flag	N