FDA Label for Night Time Severe Cold And Cough Relief
View Indications, Usage & Precautions
- DRUG FACTS ACTIVE INGREDIENTS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- 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
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRODUCT LABEL
Night Time Severe Cold And Cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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.
Drug Facts Active Ingredients
Active ingredients
(in each tablespoonful 15 mL)
Acetaminophen 325 mg
Diphenhydramine HCL 12.5 mg
Phenylephrine HCL 5mg
Purpose
Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal and sinus congestion
- runny nose
- sneezing
- itchy watery eyes
- itchy nose or throat
- cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily reduces fever
Warnings
Liver warnings: This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 6 dose in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are taking a prescription monamine 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 diphenhydramine, even one used on the skin
- for children under 4 years of age
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or empysema
- cough that occurs with too much phlegm (mucus)
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)
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcohol drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness or sleeplessness occur
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast Feeding
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 the Poison Control Center 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
Age Dose
Children under 4 years Do not use
Children 4 to under 12 years of age Do not use unless directed by a doctor
Adults and children 12 years and over 2 tablespoonful (30 mL) every 4 hours
- take only as recommended (see Overdose warning)
- use dose cup or tablespoon (TBSP)
- do not take more than 6 doses in any 24-hour period
Other Information
- each tablespoon (15 mL) contains: potassium 9 mg, sodium 6 mg
- dosage cup provided
- store between 20°-25° C (68°-7°7 F)
- do not refrigerate
Inactive Ingredients
Acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Product Label
NDC 6801-154-08
*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFUL® WARMING RELIEF COLD AND CHEST CONGESTION
Premier Value®
Night Time Severe Cold and Cough Relief
Acetaminophen ............ Pain Reliever/Fever Reducer
Diphenhydramine.......... Antihistamine/Cough Suppressant
Phenylephrine HCL ...... Nasal Congestion
Fever and Body Aches
Sore Throat
Headache
Nasal Congestion
Runny Nose
Cough
Cherry Flavor
8.3 FL OZ (245 mL)
PV Independently Tested Satisfaction Guaranteed
LF-007
DO NOT USE IF PRINTED SEAL UNDER AP IS TORN OR MISSING
Failure to follow these warnings could result in consequences
LB-007
DISTRIBUTED BY CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD SUITE 101
BOCA RATON, FL 33431
Lot:
Exp:
*This product is not manufactured or distributed b Novartis Consumer health Inc., owner of the registered trademark Theraflu® Night Time
* Please review the disclaimer below.
