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 6 hours. Do not take more than 12 tablets in 24 hours. ■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine 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.
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.
■ if you are allergic to acetaminophen
■ more than 10 days unless directed by a doctor
■ 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
■ 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 an 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 n alcohol, sedatives, and tranquilizers may increase drowsiness
■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery
■ redness or swelling is present
■ new symptoms occur
■ you get nervous, dizzy, or sleepless n 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, 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 6 hours. Do not take more than 12 tablets in 24 hours.
■ Children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
■ store at room temperature in a dry place
■ do not use if blister package is torn.
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
1-888-952-0050 Monday through Friday 9 AM - 5 PM EST
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 5 |
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 5 |
| 1046781 | APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 5 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63654-275-20 | 2020-12-07 | C162847 | 48780-1 | 9d75b9d0-c838-f424-e053-dadaa90a57ce | 275 - XL-3 Cold Medicine |
| 63654-275-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c838-f424-e053-dadaa90a57ce | 275 - XL-3 Cold Medicine |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63654-275-20 | Cold Medicine | 10 in 1 BLISTER PACK | TABLET | 10 | 5 | |
| 63654-275-20 | Cold Medicine | 2 in 1 CARTON | TABLET | 2 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63654-275 | 63654-275-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Selder, S.A. de C.V. | d2762d9c-e7e7-42b2-a26a-14b2aa0307cb | 2017-01-25 | Warnings | 63654-275-20 63654-275 63654027520 f7300376-dd92-4f5e-b68d-175e8023ca44 d2762d9c-e7e7-42b2-a26a-14b2aa0307cb |
Adverse event summaries are temporarily unavailable. Other product information remains available.