KROGER NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Kroger Nighttime Cold and Flu Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• runny nose and sneezing

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses 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, 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough as occurs with smoking, asthma, or emphysema
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• 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 (1-800-222-1222). 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
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs

• adults & children 12 yrs & over:

  30 mL every 6 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• each 30 mL contains:sodium 16 mg
• store at room temperature and do not refrigerate

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Compare to the active ingredients in VICKS ®Nyquil™ COLD & FLU Nighttime Relief*

Nighttime Cold & Flue Relief

OUR PHARAMACIST RECOMMENDED

Acetaminophen,Dextromethorphan succinate,

Doxylamine HBr

Headache, Fever, Sore Throat

Minor Aches & Pains

Sneezing, Runny Nose, Cough

Mixed Berry

Naturally and Artificially Flavored

12 FL OZ (354 mL)

Distributed by:

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks ®Nyquil™ COLD & FLU Nighttime Relief*

INGREDIENTS AND APPEARANCE

KROGER NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-292
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red (clear dark red)	Score
Shape		Size
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-292-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	01/29/2021

Labeler - Kroger Company (006999528)