CETAFEN COUGH AND COLD
- Manufacturer
- HART Health
- Effective date
- 2020-06-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:16:20
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each tablet):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose:
Pain Reliever/Fever Reducer
Cough Suppressant
Expectorant
Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses:
Temporarily relieves these cold/flu symptoms
- cough
- sore throat
- headache
- minor aches and pains
- nasal congestion
- helps loosen phlegm (mucus) and bronchial secretions to make coughs more productive
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 reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
Sore throat warning:
If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor right away.
OTC - DO NOT USE SECTION
Do not use
- with any other product containing acetaminophen (prescription or non-prescription)
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, or Pakinson's disease), or for 2 weeks after stopping the MAOI drug or if you do not know if your prescription drug contains an MAO.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- you do not know if other drugs you are taking contain acetaminophen
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart, liver or thyroid desease
- high blood pressure
- diabetes or glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
OTC - STOP USE SECTION
Stop use and ask a doctor if
- an allergic reaction occurs, seek medical help right away
- new symptoms occur
- you get nervous, dizzy, or sleepless
- pain, nasal congestion or cough gets worse or last for more than 7 days
- redness or swelling is present
- fever gets worse or lasts for more than 3 days
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
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.
OVERDOSAGE SECTION
Overdose wasrning:
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or call a Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions:
Do not take more than directed.
Adults and children 12 years of age and over:
- take 2 tablets every 6 to 8 hours while symptoms persist.
- do not take more than 8 tablets in 24 horus unless directed by a doctor
Children under 12 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1367204 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1367204 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1367204 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50332-0129-4 | 2022-01-28 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
| 50332-0129-7 | 2022-01-28 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
| 50332-0129-4 | 2021-11-22 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
| 50332-0129-7 | 2021-11-22 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
| 50332-0129-4 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
| 50332-0129-7 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1bae-fd44-e053-dadaa90aa01b | CETAFEN COUGH and COLD |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0129 | CETAFEN COUGH AND COLD (COLD MEDICINE) TABLET [HART HEALTH] | 2 | Legacy NDC | 20200607_51346b5d-5928-4aca-982c-9bc994fda43b.zip |
Products#
Every source-derived product name is available through these pages.
- CETAFEN COUGH AND COLD
- Cold Medicine
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- MALTODEXTRIN
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- STEARIC ACID
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0129 | 50332-0129-4, 50332-0129-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 |
|---|---|---|---|---|---|---|
| a79e9579-fa87-41ff-9b7b-c52dd5552252 | 51346b5d-5928-4aca-982c-9bc994fda43b | 2020-06-05 | Warnings | a79e9579-fa87-41ff-9b7b-c52dd5552252 51346b5d-5928-4aca-982c-9bc994fda43b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
