FDA Label for Nite Time Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Nite Time Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates, 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.
Active Ingredient(S)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Use(S)
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation • sore throat • headache
• minor aches & pains • fever • runny nose & sneezing
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• 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 • blisters • rash
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,
occurs with or is 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 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.
• to make a child sleep
Ask A Doctor Before Use If
• liver disease
•glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
When Using This Product
• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present • new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
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
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 6 hours
Children 4 to under 12 years of age: ask a doctor
Children under 4 years of age: do not use
Other Information
- store at room temperature 20-25 °C (68-77° F)
- do not use if blister unit is torn or open
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Nitetime Cold and Flu
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