FDA Label for Flu Relief Therapy Night Time
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Flu Relief Therapy Night Time Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar (family Wellness). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Uses
- temporarily relieves
- minor aches and pains
- sneezing
- headache
- minor sore throat pain
- itchy, watery eyes
- nasal and sinus congestion
- runny nose
- cough due to minor throat and bronchial irritation
- itchy nose or throat
- temporarily reduces fever
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
- skin reddening
- blisters
- rash
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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 product 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 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
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 use more than directed (see overdose warning)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- redness or swelling is present
- nervousness, dizziness, or sleeplessness occurs
- 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
- cough comes back or occurs with a fever, 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) immediately. 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 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 at 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 solution, 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 the active ingredients in Theraflu® Nighttime Severe Cold & Cough*
For ages 12 & over
Nighttime
Flu Relief Therapy
Severe Cold and Flu
Acetaminophen 650 mg
Pain reliever; fever reducer
Diphenhydramine HCl 25 mg
Cough suppressant; antihistamine
Phenylephrine HCl 10 mg
Nasal decongestant
Alcohol 10%
Cherry 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 Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Nighttime Severe Cold & Cough.
DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC
10401 MONROE RD
MATTHEWS, NC 28105 USA
VISIT FAMILYDOLLAR.COM
Product Label
Family Wellness Nighttime Flu Relief Therapy
* Please review the disclaimer below.