Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID dbfb8971-a122-4a97-a665-e3f0d494876e
Route
ORAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitan Sorbitol Mannitol Lecithin, Soybean Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: PC10 Shape: oval Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-30

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose

 Pain reliever/Fever Reducer Cough suppressant Antihistamine


Medication Information

Purpose

 Pain reliever/Fever Reducer

Cough suppressant

Antihistamine

Description

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 more than 2 days, is accompanied or followed by fever, headache rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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 of pharmacist before taking this product.
Package Label
QUALITY CHOICE Night Time Cold and Flu
Other Information
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink



Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredients in VICKS® NYQUIL® COLD & FLU LIQUICAPS®

Night Time

multi-symptom Relief for Cold/Flu

Acetaminophen

Dextromethorphan

Doxylamine Succinate

Pain Reliever | Fever Reducer

Cough Suppressant | Antihistamine

Alcohol Free

Softgels

(**liquid-filled capsules)

†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps®  are registered trademark of The Procter & Gamble Company.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: C.D.M.A., Inc.,©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • pain 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.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
Purpose

 Pain reliever/Fever Reducer

Cough suppressant

Antihistamine

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 more than 2 days, is accompanied or followed by fever, headache rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Do Not Use (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 of pharmacist before taking this product.
Package Label
QUALITY CHOICE Night Time Cold and Flu
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink



Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredients in VICKS® NYQUIL® COLD & FLU LIQUICAPS®

Night Time

multi-symptom Relief for Cold/Flu

Acetaminophen

Dextromethorphan

Doxylamine Succinate

Pain Reliever | Fever Reducer

Cough Suppressant | Antihistamine

Alcohol Free

Softgels

(**liquid-filled capsules)

†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps®  are registered trademark of The Procter & Gamble Company.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: C.D.M.A., Inc.,©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)