Daytime Nighttime Cold and Cough

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 (canonical bytes are SHA-256 checked before publication)

Brand name
Daytime Nighttime Cold and Cough
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE
Manufacturer
Walgreens
Product type
HUMAN OTC DRUG
SPL set ID
a99fdd49-0160-4a82-983b-fa56ab38ae76
SPL ID
5ef70d7d-ee51-4740-9002-8d00e5f52d4b
Version
9
Effective date
2025-09-08
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 05:25:17

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings DAYTIME NIGHTTIME Liver warning : This product contain acetaminophen. Severe liver damage may occur if: adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 mL each) in 24 hours taken with other drugs containing acetaminophen adult has 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. If a skin 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 DAYTIME NIGHTTIME 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 contain an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if have DAYTIME liver disease high blood pressure heart disease thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) NIGHTTIME liver disease glaucoma cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if the child is DAYTIME if you are taking the blood thinning drug warfarin NIGHTTIME taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product DAYTIME do not exceed recommended dosage. NIGHTTIME excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. NIGHTTIME pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adult as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.