OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg
Drug Facts
Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg
Purpose
Dextromethorphan HBr USP ........Cough Suppressant
Guailenesin USP ..........................Expectorant
Phenylephrine HCI, USP ...............Nasal Decongestant
Uses
■ helps loosen phlegm (mucus) and thin bronchial
secretions to drain bronchial tubes
■ temporarily relieves these symptoms occurring with
a cold:
Warnings
Do not use ■ if you are now taking aprescription
monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychialric or emotional conditions or
Parkinson's disease), or for 2 weeks aMer stopping
the MAOI drug. If you do not know il your
prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.
Ask a doctor before use if you have
■ heart disease ■ high blood pressure
■ thyroid disease ■ diabetes
■ trouble urinating due to enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with
smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use il you are
taking any other oral nasal decongestant or stimulant.
When using this product do not use more than
directed.
Stop use and ask a doctor if
■ you get nervous, diuy or sleepless
■ symptoms do not get better within 7 days or are
accompanied by fever
■ cough lasts more than 7 days, comes back or is
accompanied by fever, rash or persistent
headache. These could be signs ot aserious
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 aPoison Control Center
right away.
Directions
■ do not take more than 6 doses in any 24 hour period
■ this adult strength product is not intended for use in
children under 12 years of age
| AGE | DOSE |
Adults & children 12 years & over | 2 teaspoons every 4 hours |
| Children under 12 years | 2 teaspoons every 4 hours |
Other information
■ Keep carton for full Direction for use
■ store at 20-25ºC (68-77ºF)
■ do not refrigerate
■ dosage cup provided
■ sodium 3 mg per teaspoonful
Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin,
menthol, natural & artificial flavor, propylene glycol,
purified water, sodium benzoate, sorbitol solution,
sucralose
Questions?Call weekdays from 9:30 AM to 4:30
PM EST at
1-877·798-5944
AP SAFE NDC 76821-504-24
COMPARE TO THE ACTIVE
INGREDIENT IN ROBITUSSIN ®
PEAK COLD
MULTI-SYMPTOM COLD*
Adult Tussin
Multi-Symptom Cold
Dextromethorphan HBr / Guaifensesin /
Phenylephrine HCL
Cough Supressant / Expectorant /
Nasal Decongestant
Non-Drowsy
Relieves:
• Cough
• Mucus
• Nasal Congestion
• For Ages 12 and over
4 FL OZ (118 mL)
CF
DO NOT USE IF PRINTED SEAL UNDER
CAP IS TORN OR MISSING
5
1013430
3/20
*This product is not manufactured or distributed
by Plizer, owner of the registered trademark
Robitussin
®
Manufactured by:
AptaPharma Inc.,
1533 Union Ave,
Pennsauken, NJ 08110
Ap·BX·05
Carton
Bottle
res
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1044949 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution | PSN | 7 |
| 1044949 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 7 |
| 1044949 | dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 7 |
| 1044949 | dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0376281504248 | GTIN-13: 0376281504248 EAN-13: 0376281504248 GTIN-12: 376281504248 UPC-A: 376281504248 GTIN storage (14 digits): 00376281504248 | 504 TussinCF 4 OZ Box.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-504-24 | TUSSIN CF | 118 mL in 1 BOTTLE | LIQUID | 118 | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76281-504 | 76281-504-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | AptaPharma Inc. | c005c6cf-7891-463e-b65d-1129ad4bf6ec | 2025-12-26 | Warnings | 76281-504-24 76281-504 76281050424 46e2dfdf-5403-f692-e063-6394a90a1f17 c005c6cf-7891-463e-b65d-1129ad4bf6ec |
Adverse event summaries are temporarily unavailable. Other product information remains available.