COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled 
HyVee Inc

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Hy-Vee, Inc. Cold & Flu Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

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

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

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
•
be careful when driving a motor vehicle or operating machinery
•
avoid alcoholic drinks
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
marked drowsiness may occur

Stop use and ask a doctor if

•
pain or cough gets worse or lasts more than 7 days
•
redness or swelling is present
•
fever gets worse or lasts more than 3 days
•
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 – see overdose warning
•
do not exceed 4 doses per 24 hours

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

•
store at 20-25°C (68-77°F)

Inactive ingredients

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

*may contain this ingredient

Questions or comments?

1-800-289-8343

Package/Label Principal Display Panel

Hy•Vee®

Compare To Vicks® NyQuil® Cold & Flu Active Ingredients

Multi-Symptom Relief

Cold & Flu

Nighttime

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Doxylamine Succinate

Antihistamine

actual size

• Aches, Fever, Sore Throat

• Sneezing, Runny Nose

• Cough

ALCOHOL FREE

24 SOFTGELS

cold-&-flu
COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-056
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 HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorGREEN (clear) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code 056
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42507-056-738 in 1 CARTON03/24/201403/28/2019
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:42507-056-6212 in 1 CARTON03/24/2014
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/24/2014
Labeler - HyVee Inc (006925671)

Revised: 1/2026
Document Id: c7af5f36-0d29-48c7-9be9-27ee76658dc6
Set id: 2ce5f2af-cabc-466f-b0c5-256e6e6d4c88
Version: 5
Effective Time: 20260127
 
HyVee Inc