Combination Pack Hyvee Daytime And Nighttime Severe Cold And Flu Softgel - 24ct Kit
FDA Label NDC 42507-106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Combination Pack Hyvee Daytime And Nighttime Severe Cold And Flu Softgel - 24ct (NDC 42507-106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding daytime severe cold and flu relief, active ingredients (in each softgel), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Daytime Severe Cold And Flu Relief

Drug Facts

Active Ingredients (In Each Softgel)

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

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

Purposes

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

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 phlegm (mucus) and thin bronchial secretions to aid the bronchial passageways of bothersome mucus and make coughs more productive.

• 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

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.

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

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.

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

• 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

• 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

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

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

Inactive Ingredients

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. 

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?

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

1-888-577-8033 Mon-Fri 8am-4pm EST

Nighttime Severe Cold And Flu Relief

Drug Facts

Packaging

Daytime&nightime Cold&flu (42507106 3)

Daytime&nightime Cold&flu (42507106 3)

Daytime&nightime Cold&flu2 (42507106 4)

Daytime&nightime Cold&flu2 (42507106 4)

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