FDA Label for Daytime 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
Daytime 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 10mg
Phenylephrine HCl 5mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Use(S)
- temporarily relieves common cold/flu symptoms:
- • nasal congestion
- • cough due to minor throat & bronchial irritation
- • sore throat
- • headache
- • minor aches & pains
- • fever
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 drugs. If you do not know if your
prescription drug contains an MAOI, ask a doctor or pharmacist
before taking this product.
Ask A Doctor Before Use If
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland • cough that occurs
with too much phlegm (mucus) • persistent or chronic cough as occurs
with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If
taking the blood thinning drug warfarin.
When Using This Product
do not use more than directed
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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
Taking more than directed can cause serious health problems. 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 in 24 hours
adults and children 12 years & over: 2 softgels with water every 4 hours
children 4 to under 12 years: ask a doctor
children under 4 years: 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
FD&C red #40, FD&C yellow #6,
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
Daytime Cold and Flu
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