FAST COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled 
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kroger Co. Fast Cold & Flu Relief Drug Facts

Active ingredients (in each liquid gel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
cough
minor aches and pains
sore throat
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.
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
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

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, dizziness, or sleeplessness occur
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 (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

do not take more than directed (see Overdose warning)
do not take more than 10 liquid gels in any 24-hour period
adults and children 12 years of age and older: take 2 liquid gels every 4 hours
children under 12 years of age: do not use

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredients of MUCINEX® FAST-MAX®

COLD, FLU & SORE THROAT

See side panel

NON-DROWSY

FAST Cold & Flu Relief

COLD, FLU & SORE THROAT

MAXIMUM STRENGTH

Acetaminophen – Pain Reliever/Fever Reducer

Dextromethorphan HBr – Cough Suppressant

Guaifenesin – Expectorant

Phenylephrine HCl – Nasal Decongestant

Controls Cough, Thins & Loosens Mucus

Relieves Nasal & Chest Congestion

Relieves Headache & Fever

Our Pharmacists Recommend

16 FAST DISSOLVING LIQUID GELS (liquid filled capsules)

actual size

fast cold & flu relief image
FAST COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-506
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize25mm
FlavorImprint Code 7G0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-506-738 in 1 CARTON06/22/2017
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/22/2017
Labeler - Kroger Company (006999528)

Revised: 12/2018
Document Id: 524fc57e-1c93-4944-8b51-9281e519c1a3
Set id: 8346a794-3a19-4140-9d06-e7642c03dbf4
Version: 2
Effective Time: 20181206
 
Kroger Company