nighttime severe
7070fd17-06b2-4578-b60d-4e24df3897b5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Medication Information
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 • a sodium-restricted diet • 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.
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
Purpose
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
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
Description
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Section 42229-5
COMPARE TO VICKS® NYQUIL® SEVERE COLD & FLU ACTIVE INGREDIENTS*
MULTI-SYMPTOM RELIEF
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and NyQuil™.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Distributed by:
Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816
Product of United Arab Emirates
Section 50565-1
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Packaging
Drug Facts
Questions Or Comments?
Call 1-888-577-8033 Monday - Friday 8am - 4pm EST
Active Ingredients (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Structured Label Content
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 • a sodium-restricted diet • 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.
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
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 (Other information)
• store at 20-25°C (68-77°F) • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)
edible printing ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution
Section 42229-5 (42229-5)
COMPARE TO VICKS® NYQUIL® SEVERE COLD & FLU ACTIVE INGREDIENTS*
MULTI-SYMPTOM RELIEF
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and NyQuil™.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Distributed by:
Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816
Product of United Arab Emirates
Section 50565-1 (50565-1)
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Purposes
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Packaging
Drug Facts
Questions Or Comments? (Questions or comments?)
Call 1-888-577-8033 Monday - Friday 8am - 4pm EST
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:06.976596 · Updated: 2026-03-14T23:01:17.657881