Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 tablets every 4 hours. Do not exceed 6 doses (12 tablets) tablets in 24 hours or as directed by a doctor. · children 6 to under 12 years: take 2 tablets every 4 hours. Do not exceed 5 doses (10 tablets) in 24 hours or as directed by a doctor. · do not swallow tablets whole. Chew or crush tablets completely befor...
Drug Facts
Active ingredients (in each tablet) Purposes
Acetaminophen 162.5 mg…………….………...Pain reliever/fever reducer
Dextromethorphan hydrobromide 5 mg…….....………Cough suppressant
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache
· cough · sore throat
· temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
· adult takes more than 12 tablets in 24 hours. which is the maximum daily amount for this product
· child takes more than 5 doses in 24hours
· taken with other drugs containing acetaminophen
· adult has 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
● 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 6 years of age
Ask a doctor before use if you have
● liver disease
● cough that is accompanied by excessive phlegm (mucus)
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium restricted diet
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
· pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
· 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.
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 every 4 hours.
Do not exceed 6 doses (12 tablets) tablets in 24 hours or as directed by a
doctor.
· children 6 to under 12 years: take 2 tablets every 4 hours. Do not
exceed 5 doses (10 tablets) in 24 hours or as directed by a doctor.
· do not swallow tablets whole. Chew or crush tablets completely
before swallowing.
· children under 12 years: do not use
Other information
● each tablet contains: sodium 17 mg
● store at 20-25 oC (68-77 oF). Avoid excessive heat above 40 o C
(104 o F)
Inactive ingredients anhydrous citric acid, betadex,
carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,
magnesium stearate, mannitol, microcrystalline cellulose, polyethylene,
sodium bicarbonate, sodium starch glycolate, stearic
acid, sucralose, xylitol
Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500601715 | GTIN-13: 0016500601715 EAN-13: 0016500601715 GTIN-12: 016500601715 UPC-A: 016500601715 GTIN storage (14 digits): 00016500601715 | Final Artwork ASC Cold Cough Raspberry Fast Chewable Tablets Raspberry 24ct.jpg |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0280-8279 | 0280-8279-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| BETADEX | JV039JZZ3A | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | 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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Cough Fast | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5241b11a-72c8-5e67-e063-6394a90a4353 | 2026-05-20 | Warnings | 0280-8279-24 0280-8279 00280827924 5241b11a-72c7-5e67-e063-6394a90a4353 5241b11a-72c8-5e67-e063-6394a90a4353 |
Adverse event summaries are temporarily unavailable. Other product information remains available.