FDA Label for Daytime Cold And Flu
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
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- STORAGE
- INACTIVE INGREDIENTS
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
Daytime Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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 and flu symptoms: ■ nasal congestion ■ cough due to minor throat and bronchial irritation ■ sore throat ■ headache ■ minor aches and pains ■ fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, 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
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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 ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus)
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 n redness or swelling is present
- new symptoms occurs
- cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Pregnancy/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 per 24 hours
- Adults and children 12 years and 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
do not use if blister unit is torn or open
Storage
store at room temperature 20-25 °C (68-77° F)
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
Call 1-888-952-0050 Monday through Friday
Principal Display Panel
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