Kroger Daytime And Nighttime Cold & Flu Softgels

Kroger Daytime And Nighttime Cold & Flu Softgels
SPL v2
SPL
SPL Set ID a11d3a31-2c72-40c2-bd78-dd93903b8daf
Route
ORAL
Published
Effective Date 2025-01-09
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 Sorbitol Sorbitan Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-01-08

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 42229-5

COMPARE TO active ingredients of VICKS® DAYQUIL®/DAYQUIL® COLD & FLU RELIEF LIQUICAPS™*

POWERFUL RELIEF

DAYTIME OR NIGHTTIME

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.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO

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®, DayQuil™, NyQuilTM and LiquiCapsTM

REV.00-092024

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Section 50565-1

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.

Warnings

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, lasts 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

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 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.

Packaging

Directions

• take only as directed

• do not exceed 8 softgels 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

Other Information

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat, and moisture

Daytime Cold & Flu

Drug Facts

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Nighttime Cold & Flu

Drug Facts

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 42229-5 (42229-5)

COMPARE TO active ingredients of VICKS® DAYQUIL®/DAYQUIL® COLD & FLU RELIEF LIQUICAPS™*

POWERFUL RELIEF

DAYTIME OR NIGHTTIME

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.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO

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®, DayQuil™, NyQuilTM and LiquiCapsTM

REV.00-092024

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Section 50565-1 (50565-1)

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.

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

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, lasts 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

• trouble urinating due to enlarged prostate gland

• cough that occurs with too much phlegm (mucus)

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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 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.

Packaging

Directions

• take only as directed

• do not exceed 8 softgels 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

Other Information (Other information)

• store at room temperature between 20°-25°C (68°-77°F)

• protect from light, heat, and moisture

Daytime Cold & Flu (DayTime Cold & Flu)

Drug Facts

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Nighttime Cold & Flu (NightTime Cold & Flu)

Drug Facts

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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