Indications and uses
temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing
temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing
■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.
Acetaminophen 325 mg
Chlorpheniramine maleate 4 mg
Phenylepherine HCl 10 mg
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
temporarily relieves ■ minor aches and pains ■ headaches ■ nasal congestion ■ sinus congestion & pressure ■ runny nose ■sneezing
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product
Alergy 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
■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis
■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers
■ do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery
■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless ■ pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.
■ store at room temperature 59-86F (15-30C) ■ do not use if package is torn or damaged
Lactose monohydrate (derived from milk), Stearic acid, Povidone, Alcohol, Water purified, Hypromellose, Titanium dioxide, Triacetin, contains FDC Yellow No. 5 (tartrazine) as color additive
You may report side effects to 1-855-259-1590 Monday through Friday 9AM-5PM EST
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1193293 | acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | 7 |
| 1193293 | acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | 7 |
| 1193293 | APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 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 |
|---|---|---|---|---|---|---|
| 76095-010-01 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 76095-010-02 | Cold MedicineXL3 FORTE | 10 in 1 BLISTER PACK | TABLET | 10 | 7 | |
| 76095-010-04 | Cold MedicineXL3 FORTE | 4 in 1 PACKET | TABLET | 4 | 7 | |
| 76095-010-10 | Cold MedicineXL3 FORTE | 1 in 1 BOX | TABLET | 1 | 7 | |
| 76095-010-20 | Cold MedicineXL3 FORTE | 2 in 1 BOX | TABLET | 2 | 7 | |
| 76095-010-50 | Cold MedicineXL3 FORTE | 50 in 1 BOX | TABLET | 50 | 7 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76095-010 | COLD MEDICINE XL3 FORTE (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING INC.] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241027_58252f15-485c-3061-e053-2a91aa0a2320.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76095-010 | 76095-010-04, 76095-010-50, 76095-010-02, 76095-010-20, 76095-010-01, 76095-010-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TRIACETIN | XHX3C3X673 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
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 |
|---|---|---|---|---|---|---|
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | 76095-010-10 76095-010-01 76095-010-20 76095-010-50 76095-010-04 76095-010-02 76095-010 76095001020 76095001050 76095001010 76095001004 76095001002 76095001001 24b2650e-08a1-0752-e063-6394a90a4b90 58252f15-485c-3061-e053-2a91aa0a2320 |
Adverse event summaries are temporarily unavailable. Other product information remains available.