Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:41
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
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache
· nasal congestion · sinus congestion and pressure
· cough · sore throat
· runny nose · sneezing
· temporarily reduces fever
WARNINGS SECTION
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.
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 ● 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
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.
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 (104º F).
INACTIVE INGREDIENT SECTION
Inactive ingredients D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, 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 9AM - 5PM EST)
PDP
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1042688 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 2 |
| 1042688 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 2 |
| 1042688 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 2 |
DailyMed Pharmacologic Classes#
| 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 Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500555346 | GTIN-13: 0016500555346 EAN-13: 0016500555346 GTIN-12: 016500555346 UPC-A: 016500555346 GTIN storage (14 digits): 00016500555346 | ASP Cold Cough LG 10ct.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1570-10 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 0280-1570-10 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-20 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 | |
| 0280-1570-20 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-40 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 2 | |
| 0280-1570-40 | Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1570-20 | EA - Each | 0280-1570 | f968c35e-a547-4e42-886e-6956d7f40926 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels
- Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
- PROPYLENE GLYCOL
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C BLUE NO. 1
- GELATIN
- POVIDONE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- D&C RED NO. 33
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- WATER
- SHELLAC
- SODIUM HYDROXIDE
- SORBITAN
- ACETAMINOPHEN
- TITANIUM DIOXIDE
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-1570 | 0280-1570-20, 0280-1570-10, 0280-1570-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POVIDONE | FZ989GH94E | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SORBITOL | 506T60A25R | IACT |
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 Plus Maximum Strength Cold and Cough Liquid Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 | 2025-12-04 | Warnings | 0280-1570-10 0280-1570-20 0280-1570-40 0280-1570 00280157040 00280157010 00280157020 45267a4c-d227-b1b5-e063-6394a90a81bf 20ae92d9-fbc6-5b7a-e063-6294a90a15c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
