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 congestion sinus congestion and pressure temporarily reduces fever
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Dissolve Tablets UI1614734
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2026-08-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-08-14 00:01:17
Label at a glance#
ProductALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Acetaminophen 325 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 congestion
- sinus congestion and pressure
temporarily reduces fever
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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
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 - ASK DOCTOR SECTION
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
OTC - WHEN USING SECTION
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
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.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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 INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
OTC - QUESTIONS SECTION
Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500598916 | GTIN-13: 0016500598916 EAN-13: 0016500598916 GTIN-12: 016500598916 UPC-A: 016500598916 GTIN storage (14 digits): 00016500598916 | 92154488_ALKA_SELTZER_PLUS_ASC_Cold_Sinus_MS_24_Piece_PCE_Effervescent_Tablet_Carton.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve
- chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- CALCIUM SILICATE
- MANNITOL
- MAGNESIUM STEARATE
- POTASSIUM BICARBONATE
- SODIUM BICARBONATE
- SUCRALOSE
- POVIDONE, UNSPECIFIED
- MALTODEXTRIN
- ANHYDROUS CITRIC ACID
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-8274 | 0280-8274-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-04-27 | daily-update | 2026-06-03 18:04:13 |
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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 507284c3-cad9-d65c-e063-6394a90a58a8 | 2026-08-05 | Warnings | 0280-8274-24 0280-8274 00280827424 584e70ee-d878-6f50-e063-6394a90a051e 507284c3-cad9-d65c-e063-6394a90a58a8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.