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NDC 50580-0402-02 TYLENOL Cold Plus Flu 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details

TYLENOL Cold Plus Flu 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1

TYLENOL Cold Plus Flu is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE 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: 50580-0402-02
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: 50580-0402-02
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: 50580-0402-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

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

Related Packages: 50580-0402-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	50580-0402
Product ID	50580-402_f7a354e1-47ba-8441-e053-6294a90acf26
Associated GPIs
GCN Sequence Number	060553
GCN Sequence Number Description	phenylephrine/DM/acetaminop/GG TABLET 5-325-200 ORAL
HIC3	B4P
HIC3 Description	NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT
GCN	26742
HICL Sequence Number	035445
HICL Sequence Number Description	PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN
Brand/Generic	Brand
Proprietary Name	TYLENOL Cold Plus Flu
Proprietary Name Suffix	Severe
Non-Proprietary Name	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	325; 10; 200; 5
Active Ingredient Units	mg/1; mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Johnson & Johnson Consumer Inc.
Pharmaceutical Class	Adrenergic alpha1-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 50580-0402-02 (50580040202)

Pricing Information	N/A
NDC Package Code	50580-402-02
Billing NDC	50580040202
Package	50 POUCH in 1 CARTON (50580-402-02) / 2 TABLET, FILM COATED in 1 POUCH
Marketing Start Date	2017-07-07
NDC Exclude Flag	N