KROGER DAYTIME AND NIGHTTIME COLD AND FLU SOFTGEL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Kroger DayTime and NightTime Cold and Flu SOFTGEL by

Drug Labeling and Warnings

Kroger DayTime and NightTime Cold and Flu SOFTGEL by is a Otc medication manufactured, distributed, or labeled by The Kroger Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DayTime Cold & Flu

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:
nasal congestion  cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

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.

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

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

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

Questions or comments?

1-800-632-6900

NightTime Cold & Flu

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

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

Warnings

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.

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

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

store at room temperature between 20°-25°C (68°-77°F)
protect from light, heat, and moisture

Inactive ingredients

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?

1-800-632-6900

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

KROGER DAYTIME AND NIGHTTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59450-048

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59450-048-48	1 in 1 CARTON; Type 0: Not a Combination Product	01/08/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	32
Part 2	4 BLISTER PACK	16

Part 1 of 2

KROGER DAYTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Item Code (Source)	NDC: 59450-046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	A09
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/08/2025

Part 2 of 2

KROGER NIGHTTIME COLD AND FLU SOFTGEL 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Item Code (Source)	NDC: 59450-047
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	902
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/08/2025

Labeler - The Kroger Co. (006999528)