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NDC 36800-0515-26 topcare tussin 200 mg/10mL Details

topcare tussin 200 mg/10mL

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

MedlinePlus Drug Summary

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: 36800-0515-26
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	36800-0515
Product ID	36800-515_e2e77354-5537-469c-bc3e-3bcf04eb144e
Associated GPIs	43200010000910
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	topcare tussin
Proprietary Name Suffix	mucus plus chest congestion
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/10mL
Substance Name	GUAIFENESIN
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0515-26 (36800051526)

Pricing Information	N/A
NDC Package Code	36800-515-26
Billing NDC	36800051526
Package	1 BOTTLE in 1 CARTON (36800-515-26) / 118 mL in 1 BOTTLE
Marketing Start Date	1990-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 727ccc9b-f90e-4e39-9371-6c4a9a967558 Details

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have

•: cough that occurs with too much phlegm (mucus)
•: cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts for 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 – 20 mL every 4 hours
children under 12 years	do not use

Other information

•: store at 20-25oC (68-77oF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-888-423-0139

Principal Display Panel

NON-DROWSY

Tussin

Mucus & Chest Congestion

EXPECTORANT – GUAIFENESIN 200 mg

RELIEVES:

Mucus

Chest Congestion

Adult

For Ages 12 & Over

4 FL OZ (118 mL)

ORIGINAL FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE TUSSIN MUCUS PLUS CHEST CONGESTION

guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-515
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-515-26	1 in 1 CARTON	01/15/1990
1		118 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	01/15/1990

Labeler - Topco Associates LLC (006935977)

Revised: 6/2021

Document Id: e2e77354-5537-469c-bc3e-3bcf04eb144e

Set id: 727ccc9b-f90e-4e39-9371-6c4a9a967558

Version: 6

Effective Time: 20210604