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Severe Cold and Cough ReliefDaytime

Dosage form
LIQUID
Labeler
P & L Development, LLC
Label updated
2024-04-15
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · PHENYLEPHRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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
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.

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.

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.

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.

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 
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

Product Label

[Image in the official label — see DailyMed source]

DailyMed Set ID: 2af496a1-6fdd-4acf-9944-8b7cdf302275 · Version 3
NDC: 49580-0501