FDA Label for Flu Relief Therapy Daytime Severe Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML, 1 TABLESOON)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- 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 Daytime Severe Cold Product Label
The following document was submitted to the FDA by the labeler of this product Select Brand Dist.. 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 15 Ml, 1 Tablesoon)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves
- minor aches and pains
- headache
- minor sore throat pain
- nasal congestion
- 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 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
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 product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 accompanied by excessive 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 use more than directed (see overdose warning)
Stop Use And Ask A Doctor If
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, cough or nasal congestion gets worse or lasts more than 7 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 use in infants
- do not exceed recommended dose (see overdose warning)
- use dosage cup provided
- tbsp = tablespoon, mL = milliliter
age | dose |
adults and children 12 years and over | 2 tablespoons (30 mL) every 4 hours |
children 4 to 11 years | do not use unless directed by a doctor |
children under 4 years | do not use |
Do not take more than 6 doses (12 tablespoons) in 24 hours.
Other Information
- each 15 mL contains: sodium 8 mg
- store at room temperature
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
Daytime
Flu Relief Therapy
SEVERE COLD
Pain Reliever / Fever Reducer - Acetaminophen
Cough Suppressant - Dextromethorphan HBr
Nasal Decongestant - Phenylephrine HCl
- Nasal Congestion • Sore Throat • Headache • Body Ache • Cough • Fever
*Compare to active ingredients in Theraflu®
Distributed by: SELECT BRAND DISTRIBUTORS
Pine Bluff, AR 71603 USA AC (870) 535-3635
Alcohol Content: 10%
Cherry Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN OR MISSING.
Failure to follow the drug facts warnings could result in serious consequences.
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® Daytime.
Product Label
Select Brand Flu Relief Therapy Daytime Severe Cold Cherry Liquid
* Please review the disclaimer below.