Kroger Nighttime Cold and Flu Softgel

Manufacturer
The Kroger Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:15

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 - see Overdose warning  • do not exceed 4 doses 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)

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

Purposes

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 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, see 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. • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: Taking more than directed can cause serious health problems. 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 & for children even if you do not notice any signs or symptoms.

Directions:

DOSAGE & ADMINISTRATION SECTION

• take only as directed - see Overdose warning  • do not exceed 4 doses 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)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

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® *See bottom panel

POWERFUL NIGHTTIME RELIEF

OUR PHARMACIST RECOMMENDED

Multi-Symptom Relief

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN OR SHOWS ANY SIGN OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY
THE KROGER CO.,
CINCINNATI, OHIO 45202

MADE IN UAE

For More Product Information, Scan UPC

Using Your Kroger App or Call 800-632-6900

*This product is not manufactured or distributed by The Proctor & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Proctor & Gamble Company.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Our Brands, Our Guarantee.

Love It or Your Money Back.

www.kroger.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger -086Kroger -086

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN4
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD4
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY4

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
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-086-48Kroger Nighttime Cold and Flu Softgel12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
30142-086-48Kroger Nighttime Cold and Flu Softgel4 in 1 CARTONCAPSULE, LIQUID FILLED44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-086KROGER NIGHTTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20250101_e46291c7-6f4d-46a2-e053-2a95a90a80a1.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
30142-08630142-086-48

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 Companye46291c7-6f4d-46a2-e053-2a95a90a80a12024-12-13WarningsExact identifier
ndc (package): 30142-086-48
ndc (product): 30142-086
ndc11 (package): 30142008648
spl id: 8e180ab0-bd89-40ea-945f-44b19fb8e912
spl set id: e46291c7-6f4d-46a2-e053-2a95a90a80a1

Reported adverse events (FAERS/openFDA)#

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