Kroger Cough Cold and Flu

Manufacturer
THE KROGER CO
Effective date
2016-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:28

Label at a glance#

ProductKroger Cough Cold and Flu
Active ingredientCHOLINE SALICYLATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure17 sections

Storage and handling

Other information each 30 mL (2 TBSP) contains: Sodium 25 mg tamper evident: Do not use if foil seal under cap is broken or missing. read all product information before using store at room temperature 68°-86°F (20°-30°C) avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 30 mL (2TBSP))

Choline Salicylate (NSAID)* 870 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever / fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these common cold and flu symptoms:

  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Salicylates (NSAIDs) may cause a severe allergic reaction which may include:

  • hives
  • rash
  • shock
  • skin reddening
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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

  • if you have had an allergic reaction to salicylates (including aspirin) or any other pain reliever / fever reducer.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 2 weeks after stopping the MAOI durg. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes, or thyroid disease
  • you have a cough with excessive phlegm (mucus)
  • you have difficulty in urination due to enlargement of the prostate gland
  • you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • you have a chronic pulmonary disease or shortness of breath
  • you have a sodium restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for anticoagulation (thinning the blood) diabetes, gout, or arthritis.
  • under a doctor's care for any serious condition
  • taking a diuretic

OTC - WHEN USING SECTION

When using this product do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • pain, cough, or nasal congestion 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
  • ringing in the ears or a loss of hearling occurs
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAIDs) during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not exceed recommended dosage.
  • Do not take more than 6 doses in any 24-hour period.
  • Use enclosed dose cup
  • Keep dosage cup with product
  • TBSP=tablespoon
  • mL=milliliter
  • Adults and children 12 years and over: 30 mL (2 TBSP) every 4 hours
  • Children under 12: Do not use

STORAGE AND HANDLING SECTION

Other information

  • each 30 mL (2 TBSP) contains: Sodium 25 mg
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • read all product information before using
  • store at room temperature 68°-86°F (20°-30°C)
  • avoid excessive heat and humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients

Edetate sodium, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

OTC - QUESTIONS SECTION

Questions or comments?

1-800-632-6900

KROGER COUGH COLD & FLU 8 fl oz (234 mL) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger Cough Cold Label1Kroger Cough Cold Label1

Kroger Cough Cold Label2Kroger Cough Cold Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1653134choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN1
1653134choline salicylate 29 MG/ML / dextromethorphan hydrobromide 0.67 MG/ML / guaifenesin 6.67 MG/ML / phenylephrine hydrochloride 0.33 MG/ML Oral SolutionSCD1
1653134choline salicylate 870 MG / dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-771-082020-01-31C16284748780-19d75b9d0-9a2d-f424-e053-dadaa90a57ceKroger Cough Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-771-08Kroger Cough Cold and Flu237 mL in 1 BOTTLELIQUID2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-771KROGER COUGH COLD AND FLU (CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE KROGER CO]1Legacy NDC, 1 package rows20160701_36817db5-4b1f-7288-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-77130142-771-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
36817db5-4b20-7288-e054-00144ff88e8836817db5-4b1f-7288-e054-00144ff88e882016-06-30WarningsExact identifier
spl id: 36817db5-4b20-7288-e054-00144ff88e88
spl set id: 36817db5-4b1f-7288-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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