Qc®

Qc®
SPL v2
SPL
SPL Set ID 235ff7d1-9a26-48c9-b059-33e7f223886d
Route
ORAL
Published
Effective Date 2022-05-04
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 Water Sodium Hydroxide Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-03

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

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

Section 42229-5

Compare to the active ingredients in Vicks® NyQuil™ Severe Cold & Flu Relief LiquiCaps™*

Temporarily relieves common cold/flu symptoms:

aches, fever and sore throat

controls cough

nasal congestion

runny nose and sneezing

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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

100% QC SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of India

Packaged and Quality Assured in the USA

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

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.

Packaging

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

Drug Facts

Questions?

Call toll free: 1-888-423-0139

Other Information

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

Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Structured Label Content

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

Section 42229-5 (42229-5)

Compare to the active ingredients in Vicks® NyQuil™ Severe Cold & Flu Relief LiquiCaps™*

Temporarily relieves common cold/flu symptoms:

aches, fever and sore throat

controls cough

nasal congestion

runny nose and sneezing

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

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

100% QC SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

43157 W Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of India

Packaged and Quality Assured in the USA

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

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.

Packaging

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

Drug Facts

Questions?

Call toll free: 1-888-423-0139

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

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)