Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 7c92bdcf-db1f-4299-982f-6a3da9cba6e6
Route
ORAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg) Phenylephrine (10 mg)
Inactive Ingredients
Propylene Glycol Water Anhydrous Citric Acid Saccharin Sodium Fd&c Blue No. 1 Fd&c Red No. 40 Trisodium Citrate Dihydrate Glycerin Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-31

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCI 10 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 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCI 10 mg 

Uses
  • temporarily relieves common cold/flu symptoms:
  • nasal congestion 
  • sinus congestion and pressure 
  • cough due to minor throat and bronchial irritation  
  • minor aches and pains 
  • headache 
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • runny nose and sneezing
  • cough to help you sleep
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 4,000 mg in 24 hours, which is the maximum daily amount for this product 
  • 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 for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing.
Do Not Use
  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Product Label
Readyincase NightTime Severe Cold & Flu Berry Liquid
Other Information
  • each 30 mL contains; sodium 79 mg
  • store between 15-30ºC (59-86ºF)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum 

Questions Or Comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredients in Vicks® NyQuil® Severe Cold & Flu*

maximum strength

severe night time cold & flu 

cold & flu

Acetaminophen

dextromethorphan HBr

doxylamine succinate

phenylephrine HCI

relieves:

  • aches, fever & sore throat
  • cough
  • runny nose & sneezing
  • nasal & sinus Congestion

alcohol free

berry flavor

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble, distributor or Vicks® NyQuil® Severe Cold & Flu.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL  IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product
  • do not use more than directed (see overdose warning)
  • 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
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur 
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.

These could be a signs of a serious conditions.

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCI 10 mg 

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarges prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves common cold/flu symptoms:
  • nasal congestion 
  • sinus congestion and pressure 
  • cough due to minor throat and bronchial irritation  
  • minor aches and pains 
  • headache 
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • runny nose and sneezing
  • cough to help you sleep
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 4,000 mg in 24 hours, which is the maximum daily amount for this product 
  • 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 for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only as directed - see Overdose warning
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • do not exceed 4 doses per 24 hours
  • adults and children 12 years and over: 30 mL every 4 hours
  • children under 12 years of age: do not use
  • When using Day Time or Night Time products, carefully read each label to ensure correct dosing.
Do Not Use (Do not use)
  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Product Label
Readyincase NightTime Severe Cold & Flu Berry Liquid
Other Information (Other information)
  • each 30 mL contains; sodium 79 mg
  • store between 15-30ºC (59-86ºF)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum 

Questions Or Comments? (Questions or comments?)

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredients in Vicks® NyQuil® Severe Cold & Flu*

maximum strength

severe night time cold & flu 

cold & flu

Acetaminophen

dextromethorphan HBr

doxylamine succinate

phenylephrine HCI

relieves:

  • aches, fever & sore throat
  • cough
  • runny nose & sneezing
  • nasal & sinus Congestion

alcohol free

berry flavor

FL OZ (mL)

*This product is not manufactured or distributed by Procter & Gamble, distributor or Vicks® NyQuil® Severe Cold & Flu.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL  IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product (When using this product)
  • do not use more than directed (see overdose warning)
  • 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 (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur 
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • cough comes back, or occurs with rash or headache that lasts.

These could be a signs of a serious conditions.

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 (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCI 10 mg 

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarges prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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