Kroger NightTime Cold and Flu SOFTGEL

Manufacturer
The Kroger Co.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:22

Label at a glance#

ProductKroger NightTime Cold and Flu SOFTGEL
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing

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 6 hrs children 4 to under 12 yrs  ask a doctor children under 4 yrs  do not use

Storage and handling

• store at 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
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pains
• fever
• runny nose & sneezing

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels in 24 hrs, 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
• 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

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
• 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other information

STORAGE AND HANDLING SECTION

• store at 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 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

SPL UNCLASSIFIED SECTION

COMPARE TO the active ingredients of VICKS® NYQUIL® COLD & FLU NIGHTTIME RELIEF LIQUICAPS™*

POWERFUL NIGHTTIME RELIEF

Multi-Symptom Relief

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

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
QUALITY GUARANTEE
www.kroger.com

PRODUCT OF INDIA

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

REV.00-092024

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger-047Kroger-047

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN2
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD2
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59450-047-48Kroger NightTime Cold and Flu SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122
59450-047-48Kroger NightTime Cold and Flu SOFTGEL4 in 1 CARTONCAPSULE, LIQUID FILLED42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-047KROGER NIGHTTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE KROGER CO.]2Current NDC, 2 package rows20250123_24a73de3-e9eb-4cd4-e063-6394a90aa263.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59450-04759450-047-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
ndc (package): 59450-047-48
ndc (product): 59450-047
ndc11 (package): 59450004748
spl id: fb4c197e-d90f-43f0-a8db-b997b4748371
spl set id: 24a73de3-e9eb-4cd4-e063-6394a90aa263

Reported adverse events (FAERS/openFDA)#

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