NiteTime SEVERE Cold and Flu Relief SOFTGELS

Manufacturer
Topco Associates LLC
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:26:16

Label at a glance#

ProductNiteTime SEVERE Cold and Flu Relief SOFTGELS
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• 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...

Dosage and administration

 • take only as directed  • do not exceed 8 softgels per 24 hrs  adults & children 12 yrs & over  2 softgels with water every 4 hours  children 4 to under 12 yrs  ask a doctor  children under 4 yrs  do not use

Storage and handling

• store at controlled room temperature between 20-25°C (68-77°F) • protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextramethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

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

WARNINGS SECTION

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.

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.

Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma
• trouble urinating due to enlarged prostate gland
• 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

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, and tranquilizers may increase drowsiness

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.

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.
Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

 adults & children 12 yrs & over 2 softgels with water every 4 hours
 children 4 to under 12 yrs ask a doctor
 children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

• store at controlled room temperature between 20-25°C (68-77°F) • protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1 -888-423-0139

SPL UNCLASSIFIED SECTION

COMPARE TO VICKS® NYQUILTM SEVERE COLD & FLU LIQUICAPSTM ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO STVA0825 topcare@topco.com www.topcarebrand.com
PRODUCT OF INDIA

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks®, NyQuilTM and LiquiCaps™.

QUALITY GUARANTEED

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NiteTimeColdFluReliefNiteTimeColdFluRelief

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 CapsulePSN2
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/hJhKIc76162637-5.jpg

DailyMed Product Concepts#

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-637-24NiteTime SEVERE Cold and Flu Relief SOFTGELS2 in 1 CARTONCAPSULE, LIQUID FILLED22
76162-637-24NiteTime SEVERE Cold and Flu Relief SOFTGELS12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

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
76162-63776162-637-24

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
NiteTime SEVERE Cold and Flu Relief SOFTGELSACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC3ffe67bf-2c66-61e6-e063-6394a90a7f8f2025-12-10WarningsExact identifier
ndc (package): 76162-637-24
ndc (product): 76162-637
ndc11 (package): 76162063724
spl id: 9d7397f8-c4b7-413a-b700-dfc119c05328
spl set id: 3ffe67bf-2c66-61e6-e063-6394a90a7f8f

Reported adverse events (FAERS/openFDA)#

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