Daytime Nighttime Multi Symptom Cold Childrens

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 Multi Symptom Cold Childrens
Generic name
DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
Manufacturer
Walgreens
Product type
HUMAN OTC DRUG
SPL set ID
da4c36f5-ec79-4489-bb18-8ddab79c34bd
SPL ID
2e9e5fe3-b9d8-4399-b314-ba8d210b7f8e
Version
8
Effective date
2026-03-20
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:04

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Nighttime only Liver warning: This product contains acetaminophen . Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. NIGHTTIME with other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other drug containing diphenhydramine even one used on the skin if your child is allergic to acetaminophen or any of the inactive ingredients in this product to make a child sleepy Ask a doctor before use your if child has DAYTIME heart disease high blood pressure diabetes thyroid disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such occurs with asthma NIGHTTIME liver disease heart disease high blood disease diabetes thyroid disease glaucoma a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if your child is NIGHTTIME taking sedatives or tranquilizers. taking the blood thinning drug warfarin When using this product, Daytime do not use more than directed. Nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may ocur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough lasts more than 7 days, comes back, or occurs with a fever, rash or headache that lasts.These could be signs of a serious condition. NIGHTTIME nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 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. Keep out of reach of children. Daytime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Nighttime 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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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