Quality Choice®

Quality Choice®
SPL v2
SPL
SPL Set ID 40413cdb-68ac-70e1-e063-6394a90a9217
Route
ORAL
Published
Effective Date 2025-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-04

Description

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

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant


Medication Information

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

Section 42229-5

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

Severe Multi-Symptom Relief

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks®​, NyQuil™ and Liquicaps™.

Product of India

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

​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

Packaging

​purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

​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

• 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.

​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

​drug Facts

​other Information

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

​inactive Ingredients

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

​questions Or Comments?

Call 1-888-577-8033 Monday-Friday 8am to 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

Section 42229-5 (42229-5)

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

Severe Multi-Symptom Relief

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Procter & Gamble Company, owner of the registered trademarks Vicks®​, NyQuil™ and Liquicaps™.

Product of India

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

​uses (​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

Packaging

​purpose (​Purpose)

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

​warnings (​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

• 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.

​directions (​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

​drug Facts (​Drug Facts)

​other Information (​Other information)

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

​inactive Ingredients (​Inactive ingredients)

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

​questions Or Comments? (​Questions or comments?)

Call 1-888-577-8033 Monday-Friday 8am to 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

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