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 ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylepherine HCl 5 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 12 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 ■ 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 contains 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.Prompt 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 ■ Adults and children 12 years of age and older: take 2 tablets every 4 hours. Do not take more than 12 tablets in 24 hours ■ Children under 12 years of age: do not use in children under 12 years of age; this will provide more than the recommended dose (overdoes) and may cause liver damage.
■ store at room temperature in a dry place ■ do not use if blister package is torn.
alcohol, croscarmellose sodium, hypromellose, lactose monhydrate (derived from milk), magnesium stearate, polyethylene glycol, purified water, talc, titanium dioxide
1-855-259-1590 Monday through Friday 9AM-5PM EST
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1046781 | APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
| 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 |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76095-011-20 | Cold MedicineXL3 | 2 in 1 BOX | TABLET | 2 | 2 | |
| 76095-011-20 | Cold MedicineXL3 | 10 in 1 BLISTER PACK | TABLET | 10 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76095-011 | COLD MEDICINE XL3 (ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE) TABLET [MIDWAY IMPORTING, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241027_e41b9beb-e274-5c02-e053-2995a90ad0f8.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76095-011 | 76095-011-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | 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 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | 76095-011-20 76095-011 76095001120 24b2650e-08a2-0752-e063-6394a90a4b90 e41b9beb-e274-5c02-e053-2995a90ad0f8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.