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NDC 50580-0456-01 Childrens TYLENOL 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL Details

Childrens TYLENOL 160; 1; 5; 2.5 mg/5mL; mg/5mL; 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; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; 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: 50580-0456-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 50580-0456-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine

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: 50580-0456-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

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: 50580-0456-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	50580-0456
Product ID	50580-456_f7687494-c056-8127-e053-6294a90af6b1
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 FLU
Non-Proprietary Name	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160; 1; 5; 2.5
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL; mg/5mL
Substance Name	ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Johnson & Johnson Consumer Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

NDC 50580-0456-01 (50580045601)

Pricing Information	N/A
NDC Package Code	50580-456-01
Billing NDC	50580045601
Package	1 BOTTLE in 1 CARTON (50580-456-01) / 120 mL in 1 BOTTLE
Marketing Start Date	2017-06-26
NDC Exclude Flag	N