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Cold and Flu Severe Daytime/Nighttime

Dosage form
KIT
Labeler
Topco Associates LLC
Label updated
2023-11-06
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · DOXYLAMINE SUCCINATE · GUAIFENESIN · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
DAY TIME 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

Purposes

Pain reliever/fever reducer
Cough suppressant
Expectorant
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 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 8 softgels in 24 hrs, 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 • glaucoma • 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; taking sedatives ot tranquilizers.

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.

Label information

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

Directions

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

 adults & children 12 yrs & over  2 softgels with water
 every 4 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)
• protect from light, heat and moisture

Inactive ingredients

edible printing ink, FD&C blue no.1, FD&C red no.40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions or Comments?

Call 1-888-423-0139

NITE TIME SEVERE COLD AND FLU RELIEF

Drug Facts

Active ingredients (in each softgel)

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

Purposes

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 • 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 • glaucoma  • trouble urinating due to enlarged prostate gland • 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

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.

Label information

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

Directions

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

 adults & children 12 yrs & over  2 softgels with water
 every 4 hours
 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)
• protect from light, heat and moisture

Inactive ingredients

edible printing ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

Call 1-888-423-0139

Label information

COMBINATION PACK

COMPARE TO VICKS® DAYQUIL ™ SEVERE COLD & FLU ACTIVE INGREDIENTS*

COMPARE TO VICKS® NYQUIL ™ SEVERE COLD & FLU ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

Antihistamine Free

DO NOT TAKE THESE PRODUCTS AT THE SAME TIME

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*These products are not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® & NyQuil® Severe

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO STVA0323
[email protected] www.topcarebrand.com

PRODUCT OF UNITED ARAB EMIRATES

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

REV.01-042023

Packaging

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

DailyMed Set ID: 27ade5f8-2003-4dc6-9244-42676791e1f8 · Version 1
NDC: 76162-823