Indications and uses
temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night
- Manufacturer
- Bayer HealthCare LLC. | Contract Pharmacal Corp.
- Effective date
- 2026-06-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-06-11 05:10:30
Label at a glance#
ProductALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than the recommended dose adults and children 12 years and over: take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children under 12 years: do not use
Storage and handling
each packet contains: potassium 5 mg; sodium 5 mg store between 20 o C to 25 o C (68 o F to 77 o F)
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 packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
| Phenylephrine hydrochloride 10 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms due to a cold or flu:
- headache
- minor aches and pains
- cough
- sore throat
- nasal congestion
- sinus congestion and pressure
- runny nose
- sneezing
- temporarily reduces fever
Warnings
.
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 5 packets 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 alery: 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 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
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
- dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years: do not use
Other information
- each packet contains: potassium 5 mg; sodium 5 mg
- store between 20 oC to 25 oC (68 oF to 77 oF)
Inactive ingredients
acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate
Questions or comments?
1-800-986-0369
(Mon-Fri 8AM - 8PM EST)
SPL UNCLASSIFIED SECTION
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
PRINCIPAL DISPLAY PANEL - 6 Packet Carton
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500559399 | GTIN-13: 0016500559399 EAN-13: 0016500559399 GTIN-12: 016500559399 UPC-A: 016500559399 GTIN storage (14 digits): 00016500559399 | Final Artwork ASC Cold Flu Cong Severe Night Powder 6ct.jpg |
Products#
Every source-derived product name is available through these pages.
- ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- D&C YELLOW NO. 10
- FD&C RED NO. 40
- TRISODIUM CITRATE DIHYDRATE
- SUCRALOSE
- TARTARIC ACID
- TRIBASIC CALCIUM PHOSPHATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- STARCH, CORN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-8272 | 0280-8272-06 |
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 Flu plus Congestion Severe Fast Hot Liquid Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5349dbde-730c-610f-e063-6394a90a952a | 2026-06-02 | Warnings | 0280-8272-06 0280-8272 00280827206 5349dbde-730d-610f-e063-6394a90a952a 5349dbde-730c-610f-e063-6394a90a952a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.