Indications and 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
Alka-Seltzer Plus
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2018-02-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:03:09
Label at a glance#
ProductAlka-Seltzer Plus Severe Cold And Flu Formula
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
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
Storage and handling
each tablet contains: sodium 416 mg Phenylketonurics: Contain Phenylalanine 5.6 mg Per Tablet store at room temperature. Avoid excessive heat.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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 8 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
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.
OTC - DO NOT USE SECTION
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.
- in children under 12 years of age
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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 children
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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: sodium 416 mg
- Phenylketonurics: Contain Phenylalanine 5.6 mg Per Tablet
- store at room temperature. Avoid excessive heat.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, FD&C red #40, flavors, magnesium stearate, maltodextrin, mannitol, saccharin sodium, sodium bicarbonate
Questions or comments?
1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
PRINCIPAL DISPLAY PANEL - 20 Tablet Carton
Alka-
Seltzer
PLUS
®
Acetaminophen / Pain reliever-
fever reducer • Chlorpheniramine
maleate / Antihistamine • Dextromethorphan hydro-
bromide / Cough suppressant • Phenylephrine
hydrochloride / Nasal decongestant
SEVERE
COLD & FLU
FORMULA
CITRUS
Fever & Body Ache
Cough • Nasal Congestion
Runny Nose • Sore Throat
20 EFFERVESCENT TABLETS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | DX Film Edge | 106-7 | 85108301_20ct_Ctn.jpg |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Chlorpheniramine maleate | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| Dextromethorphan hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Chlorpheniramine | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| aspartame | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| saccharin sodium dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| sodium bicarbonate | INACTIVE INGREDIENT | 8MDF5V39QO | 1 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Severe Cold And Flu Formula
- Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride
- FD&C RED NO. 40
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- MANNITOL
- MAGNESIUM STEARATE
- MALTODEXTRIN
- SODIUM BICARBONATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-7055 | 0280-7055-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FILM COATED / ORAL | 2 mg | ||
| Acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET / SUBLINGUAL | 13 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| Acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SUSPENSION / ORAL | 45 mg/5ml | ||
| Acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAVENOUS | 1152 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | LIQUID / ORAL | 3 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, EXTENDED RELEASE / ORAL | 160 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RESPIRATORY (INHALATION) | NA | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | SOLUTION / ORAL | ADJ PH | ||
| aspartame | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | POWDER, FOR SUSPENSION / ORAL | 8000 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION / INTRATHECAL | 0.05 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, FOR SUSPENSION / ORAL | 15 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SPRAY / NASAL | 41.5 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 300 mg | ||
| Acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, FOR SUSPENSION / ORAL | 80 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | GRANULE, EFFERVESCENT / ORAL | 267 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAMUSCULAR | 101 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION, EXTENDED RELEASE / ORAL | 2464.6 mg | ||
| sodium bicarbonate | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, SOLUTION / INTRAVENOUS | 52 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER / RESPIRATORY (INHALATION) | 6 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET / SUBLINGUAL | 8 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 980.4 mg | ||
| aspartame | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 65ba586b-63c2-1dd9-e053-2991aa0a8179 | c7e71ace-c911-46cd-8c92-01385c2f7122 | 2018-02-21 | Warnings | 65ba586b-63c2-1dd9-e053-2991aa0a8179 c7e71ace-c911-46cd-8c92-01385c2f7122 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.