Flu Relief Therapy Nighttime Severe Cold
Medically reviewed on September 3, 2018
Dosage form: liquid
Ingredients: ACETAMINOPHEN 650mg in 30mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: Select Brand Dist.
NDC Code: 15127-922
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- sore throat
- runny nose
- itchy, watery eyes
- nasal and sinus congestion
- itching of the nose and throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
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 include:
- skin reddening
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.
- 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.
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- cough accompanied by excessive 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
- the blood thinning drug warfarin
- sedatives or tranquilizers
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowiness
- avoid alcoholic drinks
- marked drowiness may occur
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or last for more than 7 days
- fever gets worse or last more than 3 days
- new symptoms occur
- redness or swelling is present
- cough comes back or occurs with a fever, rash or headache that lasts
These could be signs of a serious condition.
ask a health professional before use.
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.
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24 hours 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
- each 30 mL contains: potassium 10 mg
- each 30 mL contains : sodium 14 mg
- store at 20-25ºC (68-77ºF). Do not refrigerate.
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
Flu Relief Therapy
Pain Reliever/Fever Reducer - Acetaminophen
Cough Suppressant/Antihistamine - Diphenhydramine HCl
Nasal Decongestant - Phenylephrine HCI
- Runny Nose & Sneezing
- Itchy Nose or throat
- Itchy, Watery Eyes
- Aches, Fever & Sore Throat
- Nasal Congestion
Alcohol 10 %
For Ages 12 & Over
FL OZ (mL)
*Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough
Distributed by: SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA AC (870) 535-3635
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 Novartis Consumer Health, Inc., distributor of Theraflu® Nighttime. Severe Cold & Cough.
|FLU RELIEF THERAPY NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
|Labeler - Select Brand Dist. (012578514)|