DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack

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 and Nighttime Cold/Flu Relief Softgels - Combo Pack
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE
Manufacturer
ARMY AND AIR FORCE EXCHANGE SERVICE
Product type
HUMAN OTC DRUG
SPL set ID
5f680f37-b3db-450f-b8ca-f9e31a04dc04
SPL ID
4652f477-b9fc-7ab9-e063-6294a90af9b8
Version
2
Effective date
2025-12-19
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:34:42

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use: ■ with any other products 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. Ask a doctor before use if you have ■ liver disease ■ heart disease ■ thyroid disease ■ diabetes ■ high blood pressure ■ trouble urinating due to enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistant or chronic cough as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ symptoms get worse or last more than 5 days (children) or 7 days (adults) ■ 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as 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 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include ■ skin reddening ■ blisters ■ rash. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use: ■ with any other products 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. ■ to make a child sleep. Ask a doctor before use if you have ■ liver disease ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ■ trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives & tranquilizers may increase drowsiness Stop use and ask a doctor if ■ pain or cough 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center right away. Quick medical attention is critical for adults as well as 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.