Tussin Expectorant

Manufacturer
AptaPharma, Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:49

Label at a glance#

ProductTussin Expectorant
Active ingredientGUAIFENESIN
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts


Active ingredient (in each 5 mL teaspoon)
Guaifenesin, USP ........ 100 mg

OTC - PURPOSE SECTION

Purpose
Expectorant

INDICATIONS & USAGE SECTION

Uses
■ Helps loosen phlegm (mucus) and thin bronchial
   secretions to rid the bronchial passageways of
   bothersome mucus and make coughs more
   productive

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product
■ do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
   occurs with 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 medicai 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

 12 years and over

 2-4 teaspoonfuls

  every 4 hours

 Children under 12 years   do not use

OTHER SAFETY INFORMATION

Other information
■ each 5 mL contains: sodium 3 mg
■ store between 20-2S oC (68-77°F)
■ do not refrigerate
■ dosing cup provided
■ Keep carton for full directions for use

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30AM to 4:30
PM EST at 1-877-798-5944

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE                                  NDC 76281-507-24

*COMPARE TO THE ACTIVE
INGREDIENT IN ROBITUSSIN ®
MUCUS+CHEST CONGESTION.

Adult
Tussin
Expectorant

Guaifenesin
Oral Solution, USP
Non-Drowsy

• Relieves Chest Congestion
• Loosens Mucus
• For ages 12 & Over

4 FL OZ (118 mL)

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

AP-BX-04

*This product is not manutactured or distributed by
Pfizer, the distributor of Robitussin ®Mucus plus
Chest Congestion.

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

Carton

507-24 4 OZ Box507-24 4 OZ Box

Bottle

507-24 4 OZ Btl507-24 4 OZ Btl

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN5
310604guaifenesin 20 MG/ML Oral SolutionSCD5
310604guaifenesin 100 MG per 5 ML Oral SolutionSY5
310604guaifenesin 100 MG per 5 ML Oral SyrupSY5
310604guaifenesin 200 MG per 10 ML Oral SolutionSY5
310604guaifenesin 300 MG per 15 ML Oral SolutionSY5
310604guaifenesin 400 MG per 20 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130376281507249GTIN-13: 0376281507249
EAN-13: 0376281507249
GTIN-12: 376281507249
UPC-A: 376281507249
GTIN storage (14 digits): 00376281507249
507-24 4 OZ Box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-507-24Tussin Expectorant118 mL in 1 BOTTLELIQUID1185

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-50776281-507-24

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin ExpectorantGUAIFENESINAptaPharma, Inc.ca8fa216-09c1-42b2-a95b-fa3d0f13363c2025-12-26WarningsExact identifier
ndc (package): 76281-507-24
ndc (product): 76281-507
ndc11 (package): 76281050724
spl id: 46e2f5c3-5d72-c4d3-e063-6294a90a74a0
spl set id: ca8fa216-09c1-42b2-a95b-fa3d0f13363c

Reported adverse events (FAERS/openFDA)#

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