TUSSIN COUGH

Manufacturer: AptaPharma Inc.
Effective date: 2023-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:06:07

Label at a glance#

ProductTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients (in each 5mL tsp)
Dextromethorphan HBr, USP 10mg
Guaifenesin, USP 100mg

OTC - PURPOSE SECTION

Purpose
Dextromethorphan HBr, USP .... Cough Suppressant
Guaifenesin, USP .............................. Expectorant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
Do not use ■ in a child under 12 years of age
■ if you are now taking aprescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease) or for 2 weeks atter stopping
the MAOI drug. If you do not know if your
prescription drug contains a MAOI, ask adoctor or
pharmacist before using this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or chronic, such as occurs with
smoking, asthma, chronic bronchitis or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask ahealth
professional before use.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

------------------------------------------------------------------------

Age                                       Dose
------------------------------------------------------------------------
Adults and children                 2 teaspoonfuls
12 years and over every 4 hours
------------------------------------------------------------------------
children under 12 years          do not use
_________________________________________

OTHER SAFETY INFORMATION

Other information

■ store at 20-25°C (68-77°F) ■ do not refrigerate
■ dosage cup provided ■ sodium 3 mg per
teaspoonful
■ Keep carton for full directions for use.

INACTIVE INGREDIENT SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE NDC 76281-503-24

COMPARE TO THE ACTIVE
INGREDIENTS IN ROBlTUSSIN^®
PEAK COLD COUGH & CHEST
CONGESTION DM*

Adult
Tussin
Cough

Dextromethorphan HBr / Guaifenesin

Cough Suppressant / Expectorant

Non-Drowsy
Cough Formula

• Controls Cough
• Helps Loosen chest
congestion
• For Ages 12 and over

4 FL OZ (118 mL)

CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER
CAP IS BROKEN OR MISSING.

3
1013430
3/20

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

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

AP-BX-02

Carton

503-24 Box503-24 Box

Bottle

503-24 Btl503-24 Btl

res

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	5
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	5
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	5
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	5
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	5

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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76281-503-24	2020-10-20	C162847	48780-1	9d75b9d0-13c9-f424-e053-dadaa90a57ce	8a4c55d0-c472-4e89-9fdb-17ecf0af4856
76281-503-24	2020-01-31	C162847	48780-1	9d75b9d0-13c9-f424-e053-dadaa90a57ce	8a4c55d0-c472-4e89-9fdb-17ecf0af4856

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76281-503-24	TUSSIN COUGHEXPECTORANT COUGH SUPRESSANT DM	118 mL in 1 BOTTLE	LIQUID	118		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76281-503	TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [APTAPHARMA INC.]	5	Current NDC, Legacy NDC, 1 package rows	20231231_8a4c55d0-c472-4e89-9fdb-17ecf0af4856.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM
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
76281-503	76281-503-24

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

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	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier ndc (package): 76281-503-24 ndc (product): 76281-503 ndc11 (package): 76281050324 spl id: 5b440237-78c8-458a-b365-8b77ae10fdd3 spl set id: 8a4c55d0-c472-4e89-9fdb-17ecf0af4856

Reported adverse events (FAERS/openFDA)#

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