Active Ingredients And Purpose
Active ingredient (in each caplet)
Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
■ 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.
■ 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
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 |
Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
■ 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.
■ 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)