SEVERE COLD PLUS FLU DAYTIME NIGHTTIME
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- SEVERE COLD PLUS FLU DAYTIME NIGHTTIME
- Generic name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE
- Manufacturer
- CVS Pharmacy,Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 6cb1d08b-e544-4084-b9ed-1e0d99a709c8
- SPL ID
- b31ebbd7-009f-410c-b09e-e666a6f0d9cd
- Version
- 9
- Effective date
- 2026-08-14
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:46
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M012 | openfda.application_number | |
| brand name | SEVERE COLD PLUS FLU DAYTIME NIGHTTIME | openfda.brand_name | |
| generic name | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | openfda.generic_name | |
| manufacturer name | CVS Pharmacy,Inc. | openfda.manufacturer_name | |
| ndc | package | 69842-546-12 | openfda.package_ndc |
| ndc | product | 69842-546 | openfda.product_ndc |
| ndc11 | package | 69842054612 | derived:openfda.package_ndc |
| rxcui | 1534835 | openfda.rxcui | |
| rxcui | 1550968 | openfda.rxcui | |
| rxcui | 1804384 | openfda.rxcui | |
| spl id | b31ebbd7-009f-410c-b09e-e666a6f0d9cd | id | |
| spl set id | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 6 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 ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is 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 ▪ 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 ▪ difficulty in urination due to enlargement of the prostate gland ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ cough with excessive phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
warnings
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 ALERT Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock Is 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 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 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 ▪ 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 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ALLERGY ALERT Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Is a skin or general allergic reaction occurs, stop use and seek medical help right away. ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma(wheezing) ▪ shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away.
adverse reactions
ALLERGY ALERT Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ Skin reddening ▪ Blisters ▪ Rash ▪ Hives ▪ facial swelling ▪ asthma (wheezing) ▪ shock Is a skin or general allergic reaction occurs, stop use and seek medical help right away
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.