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NDC 50580-0194-01 Childrens TYLENOL 160; 5 mg/5mL; mg/5mL Details

Childrens TYLENOL 160; 5 mg/5mL; mg/5mL

Childrens TYLENOL is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE.

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: 50580-0194-01
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: 50580-0194-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	50580-0194
Product ID	50580-194_f779ddd1-61e2-3aa8-e053-6294a90a9e40
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Childrens TYLENOL
Proprietary Name Suffix	COLD PLUS COUGH PLUS SORE THROAT
Non-Proprietary Name	Acetaminophen and Dextromethorphan Hydrobromide
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160; 5
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	Johnson & Johnson Consumer Inc.
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

NDC 50580-0194-01 (50580019401)

Pricing Information	N/A
NDC Package Code	50580-194-01
Billing NDC	50580019401
Package	1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE
Marketing Start Date	2017-06-26
NDC Exclude Flag	N