HyVee

Manufacturer
HyVee Inc
Effective date
2026-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-05 01:01:22

Label at a glance#

ProductCOMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure20 sections

Indications and uses

• temporarily relieves common cold/flu symptoms:    • nasal congestion               • sinus congestion & pressure    • cough due to minor throat & bronchial irritation    • minor aches & pains          • headache     • fever                                • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen...

Dosage and administration

• take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 years of age & over 2 softgels with water every 4 hrs children 4 to under 12 years of age ask a doctor children under 4 years of age do not use

Storage and handling

• contains FD&C yellow no.6 • store at 20-25°C (68-77°F) • protect from light, heat, and moisture

Label contents#

Full prescribing information#

DAYTIME SEVERE COLD AND FLU RELIEF

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels in 24 hours, which is the maximum daily amount for this product 
• 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 • high blood pressure
• thyroid disease • diabetes
• trouble urinating due to 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 use more than directed.

Stop use and ask a doctor if
• you get nervous, 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 rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center 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

DOSAGE & ADMINISTRATION SECTION

• take only as directed
• do not exceed 8 softgels per 24 hrs

adults & children 12 years of age & over2 softgels with water every 4 hrs
children 4 to under 12 years of ageask a doctor
children under 4 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

• contains FD&C yellow no.6 • store at 20-25°C (68-77°F)
• protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, N-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide. 

Questions or comments? 

OTC - QUESTIONS SECTION

1-888-577-8033 Mon-Fri 8am-4pm EST

NIGHTTIME SEVERE COLD AND FLU RELIEF

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves common cold/flu symptoms:
   • nasal congestion           • sinus congestion & pressure
   • cough due to minor throat & bronchial irritation
   • cough to help you sleep • minor aches & pains
   • headache    • fever        • sore throat
   • runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take 
• more than 8 softgels in 24 hours, which is the maximum daily amount for this product 
• with other drugs containing acetaminophen 
• 3 or more alcoholic drinks daily 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 • high blood pressure
• thyroid disease • diabetes • glaucoma 
• cough that occurs with too much phlegm (mucus) 
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema 
• trouble urinating due to 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
• do not use more than directed.
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
• you get nervous, 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 rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center 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

DOSAGE & ADMINISTRATION SECTION

• take only as directed
• do not exceed 8 softgels per 24 hrs

adults & children 12 years of age & over 2 softgels with water every 4 hrs 
children 4 to under 12 years of age ask a doctor 
children under 4 years of age do not use 

Other information

STORAGE AND HANDLING SECTION

• store at 20-25°C (68-77°F)
• protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, N-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Mon-Fri 8am-4pm EST

SPL UNCLASSIFIED SECTION

*Compare to the Active Ingredients of Vicks® DayQuil™ Severe Cold & Flu LiquiCaps™

Antihistamine Free

*Compare to the Active Ingredients of Vicks® NyQuil™ Severe Cold & Flu LiquiCaps™

*These products are not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® DayQuil™, NyQuil™ Severe Liquicaps™.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

DISTRIBUTED BY HY-VEE, INC.
5820 WESTOWN PARKWAY
WEST DES MOINES, IA 50266
PRODUCT OF INDIA
SATISFACTION GUARANTEED OR PURCHASE PRICE REFUNDED
FOR INFORMATION CALL
1-800-289-8343
www.hy-vee.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daytime&Nightime Cold&fluDaytime&Nightime Cold&flu

Daytime&Nightime Cold&flu2Daytime&Nightime Cold&flu2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42507-10642507-106-42
42507-836
42507-888

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ctACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEHyVee Inc82ead335-d38e-40c3-8031-222bf985a3022026-08-20WarningsExact identifier
ndc (package): 42507-106-42
ndc (product): 42507-106
ndc11 (package): 42507010642
spl id: c85c730a-fe1e-4698-9af2-f543b56ae254
spl set id: 82ead335-d38e-40c3-8031-222bf985a302
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
ndc (product): 42507-888
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
ndc (product): 42507-836

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.