■ temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: ■ sinus congestion and pressure ■ headache ■ nasal congestion ■ minor aches and pains ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever
■ do not take more than directed (see overdose warning) adults and children 12 years ■ take 2 caplets every 4 hours and over ■ swallow whole; do not crush, chew or dissolve ■ do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
Nasal decongestant
■ temporarily relieves these symptoms associated with hay fever or other
respiratory allergies, and the common cold:
■ sinus congestion and pressure ■ headache
■ nasal congestion ■ minor aches and pains
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs
more productive
■ temporarily reduces fever
Liver warning:This product contains acetaminophen. The maximum daily dose
of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver
damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may
include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients.
■ liver disease ■ heart disease
■ high blood pressure ■ thyroid disease ■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking, asthma, chronic
bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)
taking the blood thinning drug warfarin
do not exceed recommended dose
■ nervousness, dizziness, or sleeplessness occur
■ pain, nasal congestion or cough gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present ■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see overdose warning)
adults and children 12 years ■ take 2 caplets every 4 hours
and over ■ swallow whole; do not crush, chew or dissolve
■ do not take more than 10 caplets in 24 hours
children under 12 years ask a doctor
■ each caplet contains:sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not use if pouch is tron or damaged
carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 3 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 3 |
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73097-014-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-d43b-0266-e053-dadaa90a7c1a | Tylenol Sinus Severe |
| 73097-014-40 | 2023-01-30 | C162847 | 48780-1 | f386c649-d43b-0266-e053-dadaa90a7c1a | Tylenol Sinus Severe |
| 73097-014-50 | 2023-01-30 | C162847 | 48780-1 | f386c649-d43b-0266-e053-dadaa90a7c1a | Tylenol Sinus Severe |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73097-014-02 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 73097-014-40 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 73097-014-40 | Tylenol Sinus Severe | 20 in 1 CARTON | TABLET, COATED | 20 | 3 | |
| 73097-014-50 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 73097-014-50 | Tylenol Sinus Severe | 25 in 1 CARTON | TABLET, COATED | 25 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-507-01 | EA - Each | 50580-507 | ee10d929-4cd2-4906-8663-c84fe7e61be4 | 1 | 2016-01-13 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73097-014 | 73097-014-50, 73097-014-40, 73097-014-02 |
| 50580-507 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | 73097-014-50 73097-014-40 73097-014-02 73097-014 73097001440 73097001402 73097001450 518f815e-c2df-c43b-e063-6294a90a2161 8eecb3f0-eb5e-e847-e053-2995a90a86bd |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 7a60184f-91a9-4b85-b243-871deca63450 | 2024-11-01 | Warnings | 50580-507 |
Adverse event summaries are temporarily unavailable. Other product information remains available.