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cold and flu by HyVee Inc

Medically reviewed on October 30, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: HyVee Inc
NDC Code: 42507-942

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.

Hy-Vee, Inc. Cold & Flu Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses
temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
minor aches and pains
sore throat
runny nose and sneezing
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.
with any other product containing diphenhydramine, even one used on skin
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
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
pain 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

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 caplets in any 24-hour period
adults and children 12 years of age and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information
store at 20-25°C (68-77°F)
do not use if blister unit is broken or torn

Inactive ingredients

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Maximum Strength

Nighttime

COMPARE TO the Active Ingredients of Mucinex® Fast-Max® Night Time Cold & Flu

See New Warnings

Cold & Flu

Acetaminophen – Pain Reliever / Fever Reducer

Diphenhydramine HCl – Antihistamine

Phenylephrine HCl – Nasal Decongestant

ACTUAL SIZE

Relieves Aches, Fever & Sore Throat

Relieves Nasal Congestion

Relieves Runny Nose & Sneezing

For Ages 12+

20 CAPLETS

COLD AND FLU 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-942
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-942-0110 BLISTER PACK in 1 CARTON
12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/11/2015
Labeler - HyVee Inc (006925671)

 
HyVee Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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