Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Nighttime Severe Cold And Cough Liquid
FDA Label NDC 49580-0502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Nighttime Severe Cold And Cough (NDC 49580-0502). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
- temporarily relieves there symptoms due to a cold
- minor aches and pains
- headache
- sore throat
- runny nose
- sneezing
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- itching of the nose or 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- to make a child sleepy
- 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 product containing diphenhydramine, even one used on skin
- 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
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- 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
- sedatives or tranquilizers
When Using This Product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 (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
- children under 12 years of age; do not use
Other Information
- each 30 mL contains: potassium 10 mg
- each 30 mL contains: sodium 14 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
Compare to the active ingredients in Theraflu® ExpressMax® Nighttime Severe Cold & Cough *
adult nighttime Severe Cold & Cough relief
Acetaminophen 650 mg
Pain reliever/Fever reducer
Diphenhydramine HCl 25 mg
Antihistamine/Cough Suppressant
Phenylephrine HCl 10 mg
Nasal decongestant
relieves:
- Nasal Congestion
- runny nose
- cough
- sore throat
- body ache
- Fever
- headache
for ages 12 years & older
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 Health, distributor Theraflu® ExpressMax® Nighttime Severe Cold & Cough.
Manufactured by: PL Developments
11865 S. Alameda ST
Lynwood, CA 90262
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Product Label
READYinCASE Adult Night Time Severe Cold & Cough Relief Berry Flavor
* Please review the disclaimer below.
