COLD AND FLU NIGHTTIME SEVERE

Manufacturer
TARGET CORP | TIME CAP LABS INC | MARKSANS PHARMA LTD
Effective date
2024-09-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:11

Label at a glance#

ProductCOLD AND FLU NIGHTTIME SEVERE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure16 sections

Storage and handling

Other information • do not exceed 25°C

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients( in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

WARNINGS SECTION

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels 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

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

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, and tranquilizers may increase drowsiness

OTC - STOP USE SECTION

Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• pain, nasal congestion 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.

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.

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 do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take only as directed
  • do not exceed 8 softgels per 24 hrs

adults & children 12 yrs & over: 2 softgels with water every 4 hrs

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

STORAGE AND HANDLING SECTION

Other information
• do not exceed 25°C

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

626T-NYSev Cold and Flu-24ct_IFC626T-NYSev Cold and Flu-24ct_IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN4
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD4
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-983-08COLD AND FLU NIGHTTIME SEVERE1 in 1 CARTONCAPSULE, LIQUID FILLED14
11673-983-08COLD AND FLU NIGHTTIME SEVERE8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
11673-983-24COLD AND FLU NIGHTTIME SEVERE12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
11673-983-24COLD AND FLU NIGHTTIME SEVERE2 in 1 CARTONCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-983COLD AND FLU NIGHTTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TARGET CORP]4Current NDC, Legacy NDC, 4 package rows20240928_9de9c34e-a0ca-cdf9-e053-2a95a90a93d3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-98311673-983-08, 11673-983-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
ndc (package): 11673-983-08
ndc (package): 11673-983-24
ndc (product): 11673-983
ndc11 (package): 11673098308
ndc11 (package): 11673098324
spl id: 22ef568c-f6b3-924e-e063-6394a90a2d16
spl set id: 9de9c34e-a0ca-cdf9-e053-2a95a90a93d3

Reported adverse events (FAERS/openFDA)#

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