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

Kroger Nighttime Cold and Flu Softgel by

Drug Labeling and Warnings

Kroger Nighttime Cold and Flu Softgel by is a Otc medication manufactured, distributed, or labeled by The Kroger Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

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 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.

Keep out of reach of children.

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:

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:

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

Inactive ingredients:

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:

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:

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Packaging

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-086
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)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	808
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-086-48	4 in 1 CARTON	08/31/2022
1		12 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 final	part341	08/31/2022

Labeler - The Kroger Company (006999528)