Kroger Daytime And Nighttime Cold And Flu Softgel

Kroger Daytime And Nighttime Cold And Flu Softgel
SPL v7
SPL
SPL Set ID 518fbac2-9dd2-4d93-8bd6-9d057469f684
Route
ORAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-08-31

Description

Drug Facts

Purpose

Pain reliever / Fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever / Fever reducer Cough suppressant Nasal decongestant

Description

Drug Facts

Uses:

temporarily relieves common cold/flu symptoms:

• nasal congestion • cough due to minor throat & bronchial irritation • sore throat  • headache • minor aches & pains • fever

Section 34088-5

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.

Section 42229-5

COMPARE TO the active ingredients of VICKS® DAYQUIL®/NYQUIL® COLD & FLU RELIEF LIQUICAPS® ​*See side panel

POWERFUL RELIEF

DAYTIME OR NIGHT TIME

OUR PHARMACIST RECOMMENDED

Multi-Symptom Relief

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF THE BLISTER IS TORN OR BROKEN OR SHOW ANY SIGNS OF TAMPERING

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

Our Brands, Our Gurantee.

Love It or Your Money Back.

www.kroger.com

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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

Section 50565-1

Keep out of reach of children.

Purposes

Pain reliever / Fever reducer

Cough suppressant

Nasal decongestant

Packaging

Warnings:

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, occurs with or is 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.

Ask a doctor before use if you have  • liver disease  • heart disease  • high blood pressure • thyroid disease  • diabetes  • trouble urinating due to enlarged prostate gland  • cough that occurs with too much phlegm (mucus)  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

When using this product, do not use more than directed.

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

Directions:
  • 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 4 hrs
     children 4 to under 12 yrs  ask a doctor
     children under 4 yrs  do not use

Daytime Cold & Flu

Drug Facts

Other Information:
  • store at room temperature between 20-25 °C (68-77 °F)
Nighttime Cold & Flu

Drug Facts

Inactive Ingredients:

Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments:

1-800-632-6900

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses:

temporarily relieves common cold/flu symptoms:

• nasal congestion • cough due to minor throat & bronchial irritation • sore throat  • headache • minor aches & pains • fever

Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

COMPARE TO the active ingredients of VICKS® DAYQUIL®/NYQUIL® COLD & FLU RELIEF LIQUICAPS® ​*See side panel

POWERFUL RELIEF

DAYTIME OR NIGHT TIME

OUR PHARMACIST RECOMMENDED

Multi-Symptom Relief

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF THE BLISTER IS TORN OR BROKEN OR SHOW ANY SIGNS OF TAMPERING

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

Our Brands, Our Gurantee.

Love It or Your Money Back.

www.kroger.com

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Purposes

Pain reliever / Fever reducer

Cough suppressant

Nasal decongestant

Packaging

Warnings:

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, occurs with or is 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.

Ask a doctor before use if you have  • liver disease  • heart disease  • high blood pressure • thyroid disease  • diabetes  • trouble urinating due to enlarged prostate gland  • cough that occurs with too much phlegm (mucus)  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

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

When using this product, do not use more than directed.

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

Directions:
  • 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 4 hrs
     children 4 to under 12 yrs  ask a doctor
     children under 4 yrs  do not use

Daytime Cold & Flu (DayTime Cold & Flu)

Drug Facts

Other Information: (Other information:)
  • store at room temperature between 20-25 °C (68-77 °F)
Nighttime Cold & Flu (NightTime Cold & Flu)

Drug Facts

Inactive Ingredients: (Inactive ingredients:)

Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments: (Questions or comments:)

1-800-632-6900

Active Ingredients (in Each Softgel) (Active ingredients (in each Softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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