TUSSIN COUGH

Manufacturer: Salado Sales, Inc. | AptaPharma Inc.
Effective date: 2023-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:06:02

Label at a glance#

ProductTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure13 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

do not take more than 6 doses in any 24-hour period Age Dose adults & children 2 teaspoonfuls 12 years and over every 4 hours children under 12 years do not use

Contacts and useful links#

PhoneLabel contact1-877-798-5944

Websitewww.saladosales.com

www.saladosales.com

Label contents#

Full prescribing information#

Drug FactsActive ingredients ( in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

Do not use

in a child under 12 years of age
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 You Use if You Have

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than 6 doses in any 24-hour period

Age Dose

adults & children 2 teaspoonfuls
12 years and over every 4 hours

children under 12 years do not use

Other information

OTHER SAFETY INFORMATION

store at 20-25° C (66-77° F)
do not refrigerate
dosage cup provided
sodium 3 mg per teaspoon

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous citric acid, dextrose, FD & C red # 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions?

OTC - QUESTIONS SECTION

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Tussin Cough DM product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS

CVP® CONSUMER VALUE PRODUCTS

TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

NON-DROWSY COUGH FORMULA

ADULT
FOR AGES 12 AND OVER
CONTROLS COUGH
HELPS LOOSEN CHEST CONGESTION

4 FL OZ (118 Ml)

* This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold

Box-001 Rev 01

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com

LOT.

EXP.

AptaSS TussinDM 503

AptaSS TussinDM 503 1

res

AptaSS TussinDM 503

AptaSS TussinDM 503 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	8
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	8
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	8
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	8
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57243-503-24	TUSSIN COUGHEXPECTORANT COUGH SUPRESSANT DM	118 mL in 1 BOTTLE	LIQUID	118		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57243-503	TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20231230_e25727d0-7dd7-4ef5-b064-7938679f075f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	6
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	6
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	6
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	6
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	6
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	6
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	6
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	6
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
ANHYDROUS CITRIC ACID
DEXTROSE
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
MENTHOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57243-503	57243-503-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
DEXTROSE	IY9XDZ35W2	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
MENTHOL	L7T10EIP3A	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii+route 44 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / ORAL	183.66 mg		Exact identifier — unii+route 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii+route 38 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii+route 18 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii+route 22 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii+route 18 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, COATED / ORAL	132 mg		Exact identifier — unii+route 22 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii+route 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii+route 38 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SOLUTION / ORAL		10000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii+route 18 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SYRUP / ORAL	620 mg		Exact identifier — unii+route 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	PASTILLE / ORAL	826 mg		Exact identifier — unii+route 22 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii+route 22 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii+route 18 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 44 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		48 mg	Exact identifier — unii+route 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, COATED / ORAL	132 mg		Exact identifier — unii+route 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii+route 38 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / ORAL	2489 mg/5ml		Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii+route 44 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier ndc (package): 57243-503-24 ndc (product): 57243-503 ndc11 (package): 57243050324 spl id: 0019a922-379e-42b7-9443-8e313504ce1b spl set id: e25727d0-7dd7-4ef5-b064-7938679f075f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.