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NDC 36800-0516-34 topcare tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL Details

topcare tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL

topcare tussin CF is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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: 36800-0516-34
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: 36800-0516-34
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: 36800-0516-34
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0516
Product ID	36800-516_4072cabb-88fb-472d-b568-d4427286365e
Associated GPIs	43997303100908
GCN Sequence Number	000625
GCN Sequence Number Description	guaifen/dextromethorphan/PE LIQUID 100-10-5MG ORAL
HIC3	B4R
HIC3 Description	NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT
GCN	53090
HICL Sequence Number	000216
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Brand/Generic	Generic
Proprietary Name	topcare tussin CF
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	20; 200; 10
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
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

Package Images

NDC 36800-0516-34 (36800051634)

Pricing Information	N/A
NDC Package Code	36800-516-34
Billing NDC	36800051634
Package	1 BOTTLE in 1 CARTON (36800-516-34) / 237 mL in 1 BOTTLE
Marketing Start Date	2006-06-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d511afe3-2d53-4ca1-a357-fd947d506f0f Details

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 10 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

•: helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
•: temporarily relieves these symptoms occurring with a cold:
•: nasal congestion
•: cough due to minor throat and bronchial irritation

Warnings

Do not use

: if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: trouble urinating due to an enlarged prostate gland
•: cough that occurs with too much phlegm (mucus)
•: cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product

do not use more than directed

Stop use and ask a doctor if

•: you get nervous, dizzy, or sleepless
•: symptoms do not get better within 7 days or are accompanied by fever
•: cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: do not take more than 6 doses in any 24-hour period
•: measure only with dosing cup provided
•: keep dosing cup with product
•: mL = milliliter
•: this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	10 mL every 4 hours
children under 12 years	do not use

Other information

•: each 10 mL contains: sodium 5 mg
•: store at 20-25ºC (68-77ºF).
: Do not refrigerate.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO ROBITUSSIN® MULTI-SYMPTOM COLD ACTIVE INGREDIENTS

PEAK COLD

NON-DROWSY

Tussin CF

Multi-Symptom Cold

COUGH SUPPRESANT –DEXTROMETHORPHAN HBr

EXPECTORANT – GUAIFENESIN

NASAL DECONGESTANT – PHENYLEPHRINE HCl

RELIEVES:

• Cough

• Nasal Congestion

• Mucus

Adult For Ages 12 & Over

8 FL OZ (237 mL)

CHERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE TUSSIN CF

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-516
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-516-26	1 in 1 CARTON	06/12/2006	05/31/2022
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:36800-516-34	1 in 1 CARTON	06/12/2006
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/15/1992

Labeler - Topco Associates LLC (006935977)

Revised: 5/2022

Document Id: 4072cabb-88fb-472d-b568-d4427286365e

Set id: d511afe3-2d53-4ca1-a357-fd947d506f0f

Version: 6

Effective Time: 20220512