Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2af496a1-6fdd-4acf-9944-8b7cdf302275
Route
ORAL
Published
Effective Date 2024-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)
Inactive Ingredients
Acesulfame Potassium Alcohol Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-26

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Uses
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • sore throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide:

  • 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.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses (180 mL) in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 4 hours
  • chlldren under 12 years of age: 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 Severe Cold & Cough Relief
Other Information
  • each 30 mL contains: sodium 16 mg 
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions Or Comments?

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

Principal Display Panel

Compare to active ingredients of Theraflu® ExpressMax® Daytime Severe Cold & Cough*

adult day time

severe cold & cough relief

Acetaminophen 650 mg

pain reliever/fever reducer

dextromethorphan HBr 20 mg

cough suppressant

Phenylephrine HCI 10 mg

nasal decongestion

relieves:

  • cough
  • nasal congestion
  • sore throat
  • fever
  • body ache
  • headache

for ages 12 years & over

alcohol 10%

Berry Flavor

fl oz (mL)

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

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product,

do not exceed recommended dosage

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur 
  • pain, cough, or nasal congestion 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 a 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 (overdose) may 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.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves these symptoms due to a cold
    • minor aches and pains
    • headache
    • nasal and sinus congestion
    • sore throat
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide:

  • 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.

Directions
  • do not take more than directed (see overdose warning)
  • do not take more than 6 doses (180 mL) in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL every 4 hours
  • chlldren under 12 years of age: do not use 
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 Severe Cold & Cough Relief
Other Information (Other information)
  • each 30 mL contains: sodium 16 mg 
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to active ingredients of Theraflu® ExpressMax® Daytime Severe Cold & Cough*

adult day time

severe cold & cough relief

Acetaminophen 650 mg

pain reliever/fever reducer

dextromethorphan HBr 20 mg

cough suppressant

Phenylephrine HCI 10 mg

nasal decongestion

relieves:

  • cough
  • nasal congestion
  • sore throat
  • fever
  • body ache
  • headache

for ages 12 years & over

alcohol 10%

Berry Flavor

fl oz (mL)

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

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® ExpressMax® Daytime Severe Cold & Cough.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

When Using This Product, (When using this product,)

do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur 
  • pain, cough, or nasal congestion 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 a 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 (overdose) may 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.

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

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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.


Advanced Ingredient Data


Raw Label Data

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