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 8 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 4,000 mg of acetaminophen in 24 hours
· 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 with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● 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
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in childre
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 8 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 at room temperature. Avoid excessive heat.
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 9AM - 5PM EST)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536477 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral Tablet | PSN | 2 |
| 1536477 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | SCD | 2 |
| 1536477 | APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral Tablet | SY | 2 |
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| 67751-217-01 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 2 | |
| 67751-217-01 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 POUCH | TABLET, EFFERVESCENT | 1 | 2 | |
| 67751-217-02 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 2 | |
| 67751-217-02 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67751-217 | ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [NAVAJO MANUFACTURING COMPANY INC.] | 2 | Current NDC, 4 package rows | 20241004_f6068011-ad56-59b4-e053-2995a90ac016.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-217 | 67751-217-01, 67751-217-02 |
| 0280-0022 |
Every source-derived ingredient row is available through these pages.
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 Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Navajo Manufacturing Company Inc. | f6068011-ad56-59b4-e053-2995a90ac016 | 2024-10-03 | Warnings | 67751-217-01 67751-217-02 67751-217 67751021702 67751021701 2395eed2-0bab-a839-e063-6394a90aded6 f6068011-ad56-59b4-e053-2995a90ac016 |
Adverse event summaries are temporarily unavailable. Other product information remains available.