DAYTIME COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid

Daytime Cold and Flu Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • reduce swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
• help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

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

• more than 4 doses in 24 hrs which is maximum daily amount for this product
• taken 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 non-prescription). 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 an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• a sodium-restricted diet

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

• nervousness, 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 a 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
• only use the dose cup provided
• do not exceed 4 doses per 24 hours

• Adults & children 12 yrs & over:

  30 mL every 4 hrs.

• Children 4 to under 12 yrs:

  Ask a doctor

• Children under 4 yrs.:

  Do not use

Other information

• each 30 mL contains: sodium 81 mg 
• store at room temperature. Do not refrigerate

Inactive ingredients

citric acid, D&C Yellow No. 10, disodium edetate, FD&C Blue No. 1, natural and artificial flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Principal Display Panel

*Compare to the active ingredients in Vicks® Dayquil™ Severe+ VapoCOOL™

NDC: 30142-722-12

Daytime Cold & Flu Relief 

Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Phenylephrine HCI - Nasal decongestant

For Relieves of

• Minor Aches & Pains, Fever
• Nasal congestion & Sinus Pressure
• Cough
• Chest congestion

12 FL OZ (354 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

DISTRIBUTED BY THE KROGER CO.

CINCINNATI,OHIO 45202

www.kroger.com

*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Dayquil™ Severe+ VapoCOOL™

Product Label

KROGER Daytime Cold and Flu Relief

INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU RELIEF 
acetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-722
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	20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-722-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/28/2020

Labeler - The Kroger Co. (006999528)