ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels UI1613896
- Manufacturer
- Bayer HealthCare LLC. | Bayer Healthcare LLC
- Effective date
- 2026-05-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-03 18:04:07
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each capsule)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache
· cough · sore throat
· nasal congestion
· sinus congestion and pressure
· temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 10 capsules 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.
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 SECTION
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● cough that is accompanied by excessive phlegm (mucus)
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● difficulty in urination due to enlargement of the prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage
·
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 capsules with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as
directed by a doctor.
· children under 12 years: do not use
Other information
Other information
store at room temperature. Avoid excessive heat above 40ºC (104ºF).
INACTIVE INGREDIENT SECTION
Inactive ingredients FD&C yellow No.6, ferric oxide, gelatin, glycerin, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
Questions or Comments
Questions or comments? 1-800-986-0369 (Mon-Fri 8AM - 8PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500583493 | GTIN-13: 0016500583493 EAN-13: 0016500583493 GTIN-12: 016500583493 UPC-A: 016500583493 GTIN storage (14 digits): 00016500583493 | Final Artwork ASC Cold Sinus MS LG 24ct.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels
- Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride
- SODIUM HYDROXIDE
- ACETAMINOPHEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C YELLOW NO. 6
- GELATIN
- POVIDONE
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SHELLAC
- SORBITAN
- TITANIUM DIOXIDE
- SORBITOL
- POTASSIUM ALUMINUM DISILICATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-8281 | 0280-8281-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 and Sinus Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 512af63d-2f09-4baa-e063-6394a90a86bd | 2026-05-06 | Warnings | 0280-8281-24 0280-8281 00280828124 512af63d-2f08-4baa-e063-6394a90a86bd 512af63d-2f09-4baa-e063-6394a90a86bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
