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NDC 36800-0763-40 Topcare Nite Time Cold and Flu 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL Details

Topcare Nite Time Cold and Flu 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL

Topcare Nite Time Cold and Flu is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; 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: 36800-0763-40
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: 36800-0763-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine 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: 36800-0763-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

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: 36800-0763-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0763
Product ID	36800-763_825043c1-d5eb-47f1-8327-5997226e3129
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	Topcare Nite Time Cold and Flu
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	650; 20; 12.5; 10
Active Ingredient Units	mg/30mL; mg/30mL; mg/30mL; mg/30mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 36800-0763-40 (36800076340)

Pricing Information	N/A
NDC Package Code	36800-763-40
Billing NDC	36800076340
Package	355 mL in 1 BOTTLE (36800-763-40)
Marketing Start Date	2014-06-09
NDC Exclude Flag	N