FLU RELIEF COLD AND CHEST CONGESTION- acetaminohpen, guaifenesin, phenylephrine hcl liquid

Flu Relief by

Drug Labeling and Warnings

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

Guaifenesin 400mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

• for the temporary relief of
• headache
  • minor aches and pain
  • sore throat 
  • nasal and sinus congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions ot drain bronchial tubes and make coughs more productive

•  temporarily reduces fever

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours
• 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
• diabetes
• high blood pressure
• thyroid disease
• 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, 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 exceed recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur 
• pain, cough, or nasal congestion 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 the recommended dose (overdose) may cause liver damage. 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

• do not take more than directed (see Overdose warning)
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• mL = milliliter
• keep dosing cup with product
• adults and children 12 years and over:
  • 30 mL every 4 hours
• children under 12 years of age: do not use

Other information

• each 30 mL contains: potassium 10 mg
• each 30 mL contains: sodium 18 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

acesulfame potassium, benzyl alcohol, citric acid, edetate disodium, FD&C yellow #6,  flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

 1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of THERAFLU® COLD & CHEST CONGESTION *See back panel

Flu Relief 

COLD & CHEST CONGESTION

Acetaminophen 650 mg, Paon Reliever / Fever Reducer

Guaifenesin 400 mg, Expectorant

Phenylephrine HCl 10 mg, Nasal Decongestant

Adults 12 Years and Over

• Thins & Loosens Mucus
• Nasal & Sinus Congestion
• Aches, Fever, & Sore Throat

Orange Flavor

*THERAFLU® IS A REGISTERED TRADEMARK OF NOVARTIS CONSUMER HEALTH, INC., PARSIPPANY, NJ 07054. NOVARTIS CONSUMER HEALTH, INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

Product Label

Kroger Flu Relief Cold and Chest Congestion Orange Liquid

INGREDIENTS AND APPEARANCE

FLU RELIEF  COLD AND CHEST CONGESTION
acetaminohpen, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-315
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-315-08	245 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/29/2016	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/29/2016	12/31/2020

Labeler - The Kroger Co. (006999528)