Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours or as directed by a doctor. · children under 12 years: do not use
Drug Facts
Active ingredients (in each tablet) Purposes
Acetaminophen 250 mg…………….………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………………..……..Antihistamine
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Phenylephrine hydrochloride 5 mg………………….Nasal decongestant
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · runny nose · sneezing
· nasal and sinus congestion
· temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 10 tablets in 24 hours, which is the maximum daily amount for this product
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.
Do not use to sedate children
Do not use
● 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
● in children under 12 years of age
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes ● glaucoma
● cough that is accompanied by excessive phlegm (mucus)
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
When using this product
● do not exceed recommended dosage
● may cause marked drowsiness
● alcohol, sedatives, and tranquilizers may increase the drowsiness effect
● avoid alcoholic drinks
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in children
Stop use and ask a doctor if
· pain, cough, or nasal congestion 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.
· nervousness, dizziness, or sleeplessness occurs
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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 tablets fully dissolved
in 4 oz of water every 4 hours. Do not exceed 10 tablets in 24 hours
or as directed by a doctor.
· children under 12 years: do not use
Other information
● each tablet contains: potassium 80 mg; sodium 356 mg
● store between 20 oC to 25 oC (68 oF to 77 oF). Avoid excessive heat above 40 oC (104 oF).
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500598831 | GTIN-13: 0016500598831 EAN-13: 0016500598831 GTIN-12: 016500598831 UPC-A: 016500598831 GTIN storage (14 digits): 00016500598831 | Final Artwork ASC Cold Flu Cong Severe Citrus 24ct Eff.jpg |
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-8268 | 0280-8268-16, 0280-8268-24, 0280-8268-48, 0280-8268-72, 0280-8268-01 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 13 | 2025-12-04 | full-release | 2026-06-01 01:20:07 |
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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | dd7da15a-4e0b-405f-e053-2995a90a06d2 | 2026-04-28 | Warnings | 0280-8268-72 0280-8268-48 0280-8268-01 0280-8268-24 0280-8268-16 0280-8268 00280826824 00280826801 00280826872 00280826848 00280826816 5088780b-c1e6-4136-e063-6294a90a9caa dd7da15a-4e0b-405f-e053-2995a90a06d2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.