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#
Contacts and useful links#
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
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
Bottle
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310604 | guaiFENesin 100 MG in 5 mL Oral Solution | PSN | 5 |
| 310604 | guaifenesin 20 MG/ML Oral Solution | SCD | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Solution | SY | 5 |
| 310604 | guaifenesin 100 MG per 5 ML Oral Syrup | SY | 5 |
| 310604 | guaifenesin 200 MG per 10 ML Oral Solution | SY | 5 |
| 310604 | guaifenesin 300 MG per 15 ML Oral Solution | SY | 5 |
| 310604 | guaifenesin 400 MG per 20 ML Oral Solution | SY | 5 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0376281507249 | GTIN-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 | 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-507-24 | Tussin Expectorant | 118 mL in 1 BOTTLE | LIQUID | 118 | 5 |
Products#
Every source-derived product name is available through these pages.
- Tussin Expectorant
- GUAIFENESIN
- CARAMEL
- 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 |
|---|---|
| 76281-507 | 76281-507-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARAMEL | T9D99G2B1R | IACT |
| 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 |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tussin Expectorant | GUAIFENESIN | AptaPharma, Inc. | ca8fa216-09c1-42b2-a95b-fa3d0f13363c | 2025-12-26 | Warnings | 76281-507-24 76281-507 76281050724 46e2f5c3-5d72-c4d3-e063-6294a90a74a0 ca8fa216-09c1-42b2-a95b-fa3d0f13363c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

